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ANIKA INTEGRITY® IMPLANT SYSTEM · DISTRIBUTED BY LOTUS MEDICAL
Strength and biology — in one scaffold.
Integrity is a knitted hyaluronic acid scaffold that augments tendon repair with reliable strength and regenerative biology — with no animal tissue. Built for the rotator cuff. Made for the foot and ankle.
The repair holds. The healing is what fails.
Tendons have little intrinsic ability to heal, and a technically sound repair is only half the battle — the tendon still has to heal back to bone or to itself. When it doesn't, the tear comes back. Recurrence is common and front-loaded: most recurrent rotator cuff tears occur within the first six months after surgery.
10–48%
reported retear rates after rotator cuff repair
>90%
retear rate in large and massive tears
Fixation reattaches the tendon. Biology is what makes it last.
Not every patch helps the tendon heal.
Augmenting a repair with a scaffold can reinforce the construct and create an environment for healing — but the materials in use force a trade-off. Natural collagen and xenograft scaffolds are biocompatible but weaker and faster to resorb, so support fades early, and many surgeons hesitate to place animal-derived tissue. Purely synthetic patches are strong but can provoke a more aggressive inflammatory response and excess scar. The need: strength and biology in a single construct — without animal tissue.
McElvany, AJSM 2015 · Galatz, JBJS 2004 · Longo, BMC Musculoskelet Disord 2021 · Le, AJSM 2014.
A scaffold the tendon grows into — then leaves behind.
Integrity is a porous, knitted implant made of 80% Hyaff® — an esterified form of hyaluronic acid Anika has used clinically for more than 20 years — reinforced with 20% suture-grade PET for strength and handling. Placed over or around a tendon repair, its open structure supports cell infiltration and new collagenous tissue. As healing progresses, the Hyaff releases hyaluronic acid and resorbs while the PET carries load through the healing window.
It is pliable wet or dry. It can be laid on as an onlay, wrapped around a tendon, or placed between tendon and bone. It is not a xenograft and not a dermal allograft — no bovine collagen, no cadaver tissue.
Where Integrity fits
Foot & Ankle Peroneal · Achilles · Posterior tibial
Shoulder Rotator cuff (partial & full) · Subscapularis after TSA
Knee Quadriceps · Patellar
Hip & Pelvis Gluteus medius · Proximal hamstring
Engineered, down to the edge.
Material 80% Hyaff® + 20% PET, a hybrid HA-and-polyester construct.
Edges Lock-stitch construction with a laser-cut edge; thick blue borders for orientation.
Structure A flexible knit that adds tensile and shear strength, tear resistance and suture retention.
Dimensions Four sizes, 20×25 to 40×60 mm, 0.75 mm nominal thickness.
Biology the body already knows.
Hyaluronic acid is a natural building block of healing tissue. It is the primary ligand for CD44 receptors that modulate inflammation and healing, it promotes cell proliferation through TGF-β and BMP signaling, and it is central to morphogenesis — the formation of new tissue. Hyaff®-11 is a benzyl-ester form of HA that cells adhere to and that stays in the body longer than native HA, resorbing over time and releasing HA as tissue remodels. PET is suture-grade polyester, used in implants since the 1950s. Hyaff has been used clinically for more than 20 years; Anika has worked in HA for more than 30.
Strength
A permanent PET backbone that holds its strength when hydrated and sutured wet.
Biology
Hyaluronic acid, a natural binding site for the cytokines and growth factors that drive tendon healing.
No Animal Tissue Synthetic HA chemistry. Nothing bovine, porcine or cadaveric.
Measured against the market-leading collagen implant.
~50%
greater tensile strength
>3×
suture retention strength
>3×
tear resistance
~3×
thicker repaired tendon at 26 weeks
Anika bench and preclinical data versus REGENETEN®, documented in the hydrated state. In clinical evaluation of rotator cuff repair, no device-related complications were reported and no evidence of retear at 6-month follow-up.
It doesn't just hold the tendon. It rebuilds it.
Head-to-head against REGENETEN® in an established ovine infraspinatus model, histology told the story in three chapters: initial cell infiltration into the porous scaffold at 6 weeks; fibroblast infiltration and regularly oriented new collagen at 12 weeks; and at 26 weeks, a new network of tendon tissue within the resorbing implant — roughly three times the repaired-tendon thickness of the collagen implant. Added thickness reduces tendon strain and favors healing.
Integrity N=11–12 · REGENETEN N=3–4; all samples hydrated.
Data on file, Anika Therapeutics, Inc. (Walsh, SORL ANI2021-5, 2022). Schlegel, JSES 2017.
ROTATOR CUFF · ARTHROSCOPIC
The footprint came back. The tendon got thicker. Nobody re-tore.
At Florida Orthopaedic Institute, Christopher E. Baker, MD and colleagues followed ten rotator cuff patients treated with Integrity — four partial-thickness tears repaired with the implant as an onlay, six full-thickness tears augmented on the bursal side after a standard double-row repair — with MRI and patient-reported outcomes at three and six months.
On MRI, mean tendon thickness rose from 4.77 mm before surgery to 7.63 mm at three months and held at 7.61 mm at six — a 60% gain (p<0.001). The rotator cuff footprint was restored in every patient. At three months every shoulder showed an abundant subacromial healing response; by six months it appeared more organized and incorporated.
Patients felt it. SANE rose from 37.7 to 79.8, ASES from 40.5 to 76.5, and PROMIS Physical from 42.6 to 47.1 at six months. Zero adverse events: no recurrent tears, no repair failures, no reoperations.
+60%
tendon thickness at 3 months (4.77 → 7.63 mm)
100%
footprint restored on MRI
37.7 → 79.8
SANE score at 6 months
0
retears · 0 failures · 0 reoperations
"Most recurrent tears occur within 6 months postoperatively. Augmenting with an HA-based patch improves rotator cuff repair integrity and potentially patient outcomes."
— Christopher E. Baker, MD, Florida Orthopaedic Institute
Who it's for
Young patients with atraumatic tears. Chronic retracted tears. Repairs with significant degenerative tissue — the shoulders most likely to fail a fixation-only repair.
The technique, lateral-first
1. A 12 mm soft cannula through the lateral working portal, with a dilator to ease implant passage.
2. Insert the implant with the PEEK bone staple and impact it along the lateral row — lateral-first fixation makes single-portal placement simple.
3. Pull back on the cannula while advancing the wheel to deploy the implant over the repair.
4. Seat it with PLGA tissue tacks, medial to lateral and anterior to posterior, until the footprint is fully covered.
Partial-thickness onlay repairs in the series came out of the sling on day three with early passive motion; full-thickness repairs follow the surgeon's usual protocol.
Porter — 29 patients. Significant gains in flexion, pain and strength through 6 months. No device-related complications. No clinical evidence of retear at 6 months.
Read the Baker MRI series →Read the technique paper →Request the shoulder technique guide →
Moore, Patel, Cardona, Sochor, Cohen, Baker. JOEI 2026;7(1). Patel, Moore, Chase, Kucharik, Sochor, Cardona, Baker. Arthroscopy Techniques 2025. Porter & Pietrzak, Anika white paper 2025 (AML-900-735).
FOOT & ANKLE · PERONEAL TENDONS
Wrap the repair. Keep the tendon gliding.
Longitudinal split tears of the peroneus brevis are among the hardest soft-tissue problems in the foot and ankle to heal well: the torn zone thickens, scars and stops gliding in the retromalleolar groove. Integrity gives the surgeon a thin, pliable scaffold that wraps the tubularized repair circumferentially — adding strength and a biologic environment at the tear without the bulk of a dermal graft.
Technique, in brief
1. Expose the sheath from the retromalleolar groove to the peroneal tubercle, protecting the sural nerve.
2. Identify brevis and longus; debride the tear and freshen the inner surface.
3. Repair and tubularize the tendon with suture of choice.
4. Optional: hydrate the implant in bone marrow aspirate concentrate.
5. Wrap Integrity around the tendon over the affected zone; secure with a running 4-0 absorbable suture to minimize knot irritation.
6. Reapproximate the sheath and repair the retinaculum so the tendon glides and does not subluxate.
Recovery
Published protocol: three weeks non-weight-bearing, three weeks protected in a boot, therapy from week 3–4. Surgeons using Integrity report walking peroneal repairs at three weeks.
Why it fits the peroneals
Thin enough to close the sheath over. Pliable enough to wrap a small tendon. Strong enough to suture wet. And it resorbs — nothing bulky stays behind to rub inside the groove.
Abbreviated from the Anika Integrity™ Peroneal Tendon Repair Surgical Technique Guide (AML-900-690). Refer to the IFU.
FOOT & ANKLE · ACHILLES TENDON
Give the Achilles every advantage to heal — and to move sooner.
The Achilles is the most-operated tendon in the foot and ankle: acute ruptures, insertional tendinopathy with spur resection, chronic tendinosis, lengthenings and reconstructions. The surgical repair itself is rarely the problem. The problem is what comes after — a stiff, scarred, hypertrophied tendon, a slow return to motion, and the ever-present risk of re-rupture in a poorly vascularized tissue.
Integrity was made for this tendon. The larger 25×60 and 40×60 mm sizes wrap an Achilles completely, so the repair sits inside a scaffold of hyaluronic acid rather than under a patch. In insertional repairs, it can be placed between bone and tendon to support reattachment to the calcaneus. And because it is thin and pliable, the paratenon and skin still close over it — the closure problem that made thick dermal grafts and stiff synthetic meshes hard to live with.
Acute Rupture Repair with your suture construct, then wrap the repair zone to add strength and biology to the healing tendon.
Insertional Tendinopathy After spur resection and reattachment, place Integrity at the bone–tendon interface as the Hyaff resorbs into a healing environment.
Chronic / Revision / Lengthening For the thin, poor-quality tendon after Z-lengthening or revision, wrap to find good tissue to suture into and support remodeling.
The rehab argument
Fifty years ago an Achilles repair was casted for twelve weeks. The field has moved toward early motion because the tendon heals better when it moves. Augmentation that adds strength and biology to the repair is what lets a surgeon be confident in an earlier protocol.
"If I was having my own Achilles fixed, I would want every possible thing in there that would help it heal faster."
One implant across the foot and ankle — and beyond.
Indicated for the management and protection of tendon injuries where there is no substantial loss of tendon tissue: rotator cuff (full and partial thickness), Achilles rupture, peroneal tendon, posterior tibial tendon repair and transfer, gluteus medius, patellar and quadriceps tendon. Wrap it, onlay it, or interpose it — the same scaffold, the same biology.
Load it with the patient's own biology. Sew it down wet.
Foot and ankle and sports-medicine surgeons already harvest bone marrow aspirate concentrate — from the calcaneus or distal tibia, in the same field, in about fifteen minutes. Today most of it is injected or simply runs off the repair. Integrity gives that biology a home. The scaffold more than doubles its weight in BMAC, PRP or blood, holds the fluid, keeps its tensile strength wet, and can be sutured hydrated. Then the hyaluronic acid carries the patient's own growth factors and cells to the repair and resorbs as native tissue forms. No new workflow — more retained biology.
Soak a fully resorbable competitor in BMAC on the back table and watch what happens to its strength. Integrity holds because of the permanent PET backbone.
What a patch cannot do.
Dermal Allografts Strong, but bulky, permanent, and hard to close skin over a tight Achilles. Integrity is thin and resorbs.
Collagen Inductive Implants Bioinductive but not structural; not built to be soaked and sutured wet. Integrity adds strength and biology.
Synthetic Mesh Abrasive, stiff, and stays forever. Integrity is pliable, non-abrasive to surrounding tissue, and the HA leaves.
No-Stretch Suture Alone Permanent bulk in the tendon with no biologic contribution. Integrity works with your suture construct.
Nothing The default. Integrity is the "why not" for every tendon repair a surgeon wants to heal faster and move sooner.
The only patch that does all three.
Integrity is the only augmentation patch combining high strength, a streamlined bone-and-tendon delivery system, and HA-based regenerative biology — without animal tissue.
Integrity™ (Anika): HYAFF® + PET — high implant strength ✓ · streamlined tendon + bone delivery ✓ · regenerative biology ✓
REGENETEN™ (Smith+Nephew): Type 1 collagen — strength ✕ · delivery ✓ · biology ✓
Tapestry® (Zimmer Biomet): Collagen + PDLLA — strength ✕ · delivery ✓ · biology ✓
BioBrace® (ConMed): Collagen + PLLA — strength ✓ · delivery ✕ · biology ✓
CuffMend™ (Arthrex): Acellular dermis — strength ✓ · delivery ✕ · biology ✕
Improved cellular response in internal studies vs. REGENETEN. CuffMend: surgeon perception of mixed clinical results / higher failure rates (SmartTrak 2023).
One system. A simpler technique.
Integrity Implant 80% Hyaff® + 20% PET knit · four sizes · 0.75 mm.
Bone Staple PEEK, 16 one-way fins; fixes the implant to bone.
Tissue Tack PLGA, resorbs in 6–12 months; 7 and 8 mm; fixes the implant to soft tissue.
Technique by tendon
Rotator Cuff "Lateral-first" dual portal: staple to bone, roll out, tissue tacks.
Achilles / Peroneal Wrap the zone of injury; running 4-0 absorbable suture.
Gluteus Medius Lay over the repair; suture-bridge or pulley to compress.
Sizes
6000100 · 20 × 25 mm · Peroneal, posterior tibial, small tendons
6000101 · 25 × 30 mm · Peroneal wrap, rotator cuff
6000113 · 25 × 60 mm · Achilles wrap, long peroneal tears
6000114 · 40 × 60 mm · Full Achilles circumferential wrap, large cuffs
0.75 mm nominal thickness · 80% Hyaff® / 20% PET · supplied sterile, single use.