Who is the manufacturer of Integrity Implant?

Anika Therapeutics, Inc. filed the 510(k) submission for Integrity Implant (K223538).

What is the FDA product code for Integrity Implant?

OWX. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Integrity Implant?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Integrity Implant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Integrity Implant

Q: What are the predicate devices for Integrity Implant?

Collagen Tendon Sheet (K112423).

K223538 · Anika Therapeutics, Inc. · OWX · Aug 17, 2023 · General, Plastic Surgery

Device Facts

Record ID	K223538
Device Name	Integrity Implant
Applicant	Anika Therapeutics, Inc.
Product Code	OWX · General, Plastic Surgery
Decision Date	Aug 17, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Device Story

Integrity Implant is a partially resorbable, knitted, porous mesh patch composed of Hyaff (esterified hyaluronic acid) and PET fibers. Designed for use by board-certified surgeons in open or arthroscopic surgical environments, the device acts as a protective layer to physically separate damaged tendons from surrounding tissues during healing. It is fixated to bone via anchors and to the tendon via sutures or anchors. The device provides an augmentation layer; it is not intended to replace substantial tendon loss. Over 4-6 months, the Hyaff component resorbs, while the PET remains to provide structural integrity and mechanical strength. The patch is provided sterile for single use. By protecting the repair site, the device supports regenerative scaffold formation and new collagenous tissue growth, potentially improving healing outcomes for patients with tendon injuries.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing and a prospective animal study. Animal study: 47 skeletally mature sheep (bilateral infraspinatus model) compared subject device, predicate, and control at 6, 12, and 26 weeks. Endpoints included gross macroscopic appearance, radiography, Micro-CT, 3T MRI, tensile testing, and histology. Results showed no adverse reactions, equivalent mechanical properties to the predicate, and successful fibroblast infiltration/collagenous tissue formation. Bench testing included sterility, shelf life, dimensions, pore size, patch stiffness, compliance, tear resistance, and suture pull-out strength.

Technological Characteristics

Knitted porous mesh; materials: Hyaff (esterified hyaluronic acid) and PET (poly(ethylene terephthalate)) with D&C Blue No. 6. Dimensions: 20mm x 25mm and 25mm x 30mm. Sterilization: Gamma irradiation. Biocompatibility per ISO 10993-1 for long-term implant (>30 days). Mechanical properties include suture pull-out strength and patch compliance.

Indications for Use

Indicated for management and protection of tendon injuries without substantial loss of tendon tissue in patients requiring surgical tendon repair.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

Collagen Tendon Sheet (K112423)

Reference Devices

Versawrap Tendon Protector (K160364)
Tapestry Biointegrative Implant (K201572)
HyaloMatrix PA (K073251)
Pitch-Patch (K211563)

Related Devices

K250997 — Integrity Implant · Anika Therapeutics, Inc. · Jun 17, 2025
K220867 — Tapestry Biointegrative Implant · Embody, Inc. · May 23, 2022
K252647 — Tapestry Biointegrative Implant · Embody, Inc. · Sep 19, 2025
K212306 — Tapestry Biointegrative Implant · Embody, Inc. · Nov 2, 2021
K201572 — TAPESTRY Biointegrative Implant · Embody, Inc. · Oct 19, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ August 17, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Anika Therapeutics, Inc. Wei Zhao Executive Director, Regulatory Affairs 32 Wiggins Ave. Bedford, Massachusetts 01730 Re: K223538 Trade/Device Name: IntegrityTM Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWX Dated: July 18, 2023 Received: July 18, 2023 Dear Wei Zhao: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jesse Muir -S Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223538 Device Name Integrity Implant ### Indications for Use (Describe) The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K223538 Page 1 of 5 # 510(k) Summary #### l. SUBMITTER Anika Therapeutics, Inc. 32 Wiggins Avenue Bedford, MA 01730 Phone: 781-457-9000 Contact Person: Wei Zhao, Executive Director, Regulatory Affairs Date Prepared: August 15, 2023 #### II. DEVICE Name of Device: Integrity™ Implant Common or Usual Name: Tendon Protector Classification Name: Mesh, Surgical (878.3300) Regulatory Class: II Product Code: OWX #### III. PREDICATE DEVICE Collagen Tendon Sheet, K112423 #### IV. REFERENCE DEVICES Versawrap Tendon Protector, K160364 Tapestry Biointegrative Implant, K201572 HyaloMatrix PA, K073251 Pitch-Patch, K211563 #### V. DEVICE DESCRIPTION The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state. The Integrity Implant will be made available in 2 sizes: - 20mm X 25mm - 25mm X 30mm {4}------------------------------------------------ ### K223538 Page 2 of 5 The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body. The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor. #### VI. INDICTATIONS FOR USE The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. #### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE A table comparing the key features of the subject and predicate device is provided below. | | Integrity Implant (Subject Device) | Collagen Tendon Sheet (Predicate Device) | Discussion | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | 510(K) No. | TBD | K112423 | N/A | | Device Class | Class II | Class II | Same | | Product Code | OWX | FTM | Same | | Classification | Mesh, Surgical | Mesh, Surgical | Same | | Intended Use/ Indication for Use | Management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. | Management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. | Same | | Material Type | Hyaff and PET | Type I Collagen | See "Discussion of Differences" below | | Resorbable | Partial | Yes | See "Discussion of Differences" below | | Configuration | Sheet | Sheet | Same | | Nominal Sizes | 20 X 25 mm (2.0 X 2.5 cm) 25 X 30 mm (2.5 X 3.0 cm) | 2 X 2.5 cm 2.5 X 3 cm | Same | | Reusable | No | No | Same | | Packaging | Tray within a peel pouch | Double peel package | See "Discussion of Differences" below | | Sterilization | Gamma Irradiation | Gamma Irradiation | Same | {5}------------------------------------------------ # K223538 Page 3 of 5 ### Discussion of Differences ### Material: The subject device differs from the predicate in its material type. The subject device is composed of Hyaff, (esterified hyaluronic acid [HA]) and PET. The predicate device is composed of Type I Collagen derived from bovine Achilles' tendon. The PET (natural and with D&C Blue No. 6) used in the subject device has been added for structural integrity and increased mechanical strength. The PET with D&C Blue No. 6 was added for visibility during surgical procedures. Despite differences in the material type, the subject device has been proven substantially equivalent per performance testing. ### Resorption: The predicate device is considered fully resorbable, while the subject device is considered partially resorbable. The majority of the subject device (Hyaff portion) will be resorbed with the PET remaining. PET has a long history of demonstrated biocompatibility and is used in numerous FDA approved implantable devices that include high-strength polyester sutures. ### Packaging: The predicate and subject device both have similar packaging systems consist of a double peel package. The predicate device has a secondary sterile barrier that also provides additional protection. Both packaging configurations ensure sterile integrity of the applicable device. #### VIII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing The Integrity Implant is characterized according to ISO 10993-1 as an implant medical device having long-term contact duration (≥30d) to tissue/bone. The biocompatibility evaluation for the Integrity Implant was conducted in accordance with the FDA guidance document issued on September 4, 2020: "Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The endpoints of biological evaluation included the following tests: - Chemical Characterization/Toxicological Risk Assessment ● - Cytotoxicity - Sensitization ● - Irritation - Systemic toxicity - Material Mediated Pyrogenicity - Bacterial Endotoxin (LAL) - Genotoxicity - . Implantation/Biodegradation ### Performance Testing - Bench The following bench tests were performed on the Integrity Implant: {6}------------------------------------------------ - Sterility ● - Shelf Life - Dimensions - Thickness - Mesh Basis Weight/Density - Mesh Knit Characteristics - Pore Size - Patch Stiffness - Patch Compliance - Tear Resistance - Suture Pull-out/Retention Strength ● - Bacterial Endotoxin Limits - . Residual Solvents ### Performance Testing - Animal The purpose of the study was to characterize bone ingrowth, local tissue responses and biomechanical effectiveness of repair of the rotator cuff with the Integrity Implant against the predicate, Collagen Tendon Sheet (Regeneten), and a control. An adult bilateral infraspinatus model with time points at 6, 12 and 26 weeks was used. A total of forty-seven (47) skeletally mature sheep were enrolled. The specific aims of the study at 6, 12 and 26 weeks were: - To evaluate the gross macroscopic appearance - To evaluate the radiographic changes based on AP and lateral radiographs and Micro-Computed Tomography. - To evaluate the mechanical properties of the repair. - To evaluate and compare the histological responses. ● There were no study related complications or premature deaths in this study. All surgical procedures were completed without incident. No adverse reactions were noted in the in-life phase of the study and all animals ambulated normally throughout the study periods. Gross dissections and harvest did not reveal any adverse reactions in the subject, predicate, or control groups. Blood work and distant organ pathology were normal for all animals in this study. Radiographic endpoints using radiographs and micro-computed tomography and 3T MRI scanning demonstrated no adverse reactions. Tensile testing of the repaired rotator cuff demonstrated that the subject device and the predicate device performed substantially equivalent and, did not reveal any differences between the groups. Histology results from the current study demonstrated that the subject and predicate devices resorb with time providing a substantially equivalent regenerative scaffold for new collagenous tissue formation. Both the Subject and Predicate device supported new collagen tissue formation via fibroblasts that infiltrated over and within the devices. No questions regarding the efficacy of the Integrity Implant were raised and the subject and predicate devices can be viewed as substantially equivalent based on the outcomes of the animal study. {7}------------------------------------------------ # Clinical Data No clinical studies were conducted using the Integrity Implant prior to the 510(k) submission. ### Conclusions The Integrity Implant is considered substantially equivalent to the Collagen Tendon Sheet. The two devices have the same indication. Both devices have similar characteristics. Testing data also indicated the performance characteristics of the two devices is substantially equivalent. Any differences in characteristics, such as the material, do not raise additional questions of safety and effectiveness.