← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K103712 # GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD (K103712) _Depuy Mitek, A Johnson & Johnson Company · HWC · Mar 11, 2011 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K103712 ## Device Facts - **Applicant:** Depuy Mitek, A Johnson & Johnson Company - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Mar 11, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular repair, acetabular labral repair. ## Device Story Non-absorbable, 3.0mm threaded suture anchor manufactured from PEEK; preloaded on disposable inserter assembly. Used for fixation of #2 suture to bone during orthopedic soft tissue repair procedures. Operated by surgeons in clinical/OR settings. Provides mechanical anchor point in bone to secure sutures; facilitates tissue-to-bone reattachment. Benefits include stable fixation for ligament/tendon repairs. Offered with Orthocord suture options. ## Clinical Evidence Bench testing only. Assessments included pull-out testing, shelf-life, sterilization, and biocompatibility. No clinical data presented. ## Technological Characteristics Material: PEEK. Form factor: 3.0mm threaded anchor. Delivery: Disposable inserter assembly. Suture compatibility: #2 suture (including Orthocord). Sterilization: Not specified. Connectivity: None (mechanical device). ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Gryphon BR Anchor - Hip ([K100012](/device/K100012.md)) - Gryphon P BR Anchor ([K090124](/device/K090124.md)) - Healix Peek Anchor ([K071481](/device/K071481.md)) - TransTend Anchor ([K102298](/device/K102298.md)) - Gryphon BR and Healix BR Anchor ([K073412](/device/K073412.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K103712 p11/2 ## 510(k) SUMMARY MAR 1 1 2011 ## Gryphon PEEK Anchor | Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Contact Person | Kristine Christo
Project Manager, Regulatory Affairs
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Telephone:
508-828-3359
Facsimile:
508-977-6355
e-mail: | KChristo@its.jnj.com | | Name of Medical Device | Classification Name: | Fastener, Fixation, Nondegradable, Soft
Tissue Smooth or threaded metallic bone
fixation fasteners | | | Common/Usual Name: | Bone Anchor | | | Proprietary Name: | Gryphon PEEK Anchor | | Substantial Equivalence | Gryphon PEEK Anchors are substantially equivalent to:
K100012 Gryphon BR Anchor -Hip (April 30, 2010) K090124 Gryphon P BR Anchor (March 11, 2009); K071481 Healix Peek Anchor (August 9, 2007) K102298 TransTend Anchor (January 7, 2011) K073412 Gryphon BR and Healix BR Anchor (January 17, 2008) | | | Device Classification | This device carries an FDA product code HWC and is classified as
Single/Multiple component metallic bone fixation appliances and
fasteners under 21 CFR 888.3030. This device is offered with
Orthocord suture (K040004, K043298). | | {1}------------------------------------------------ Device Description The Gryphon PEEK Anchors are non-absorbable threaded suture anchors manufactured of PEEK material. The barbed anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Gryphon PEEK Anchor is provided as size 3.0mm. The Gryphon PEEK Anchors will be offered with partially absorbable Orthocord suture options, similar to the Gryphon P BR Anchor. Technologies characteristics including design and packaging are the same as the predicate cleared devices. Indications for Use The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair. SLAP Lesion Repair. Bicens Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair. Non clinical Testing Verification activities were performed on the implant or its predicates. Testing assessments include pull out testing. shelf-life, sterilization and biocompatibility. Safety and Performance Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices. Gryphon PEEK Anchors are similar to: Gryphon P BR Anchor (K100012, K090124), Healix Peek Anchor (K071481) and TransTend Anchor (102298). Based on the indications for use, technological characteristics, and comparison to predicate devices, the Gryphon PEEK Anchors have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DePuy Mitek % Ms. Kristine Christo Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767 MAR 1 1 291 Re: K103712 Trade/Device Name: Gryphon PEEK Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HWC Dated: December 17, 2010 Received: December 20, 2010 Dear Ms. Christo: 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. 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. {3}------------------------------------------------ Page 2 - Ms. Kristine Christo 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Ary B. Rh for Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K \ 037\2 Device Name: Gryphon PEEK Anchor Indications for Use: The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular repair, acetabular labral repair. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 for M. Melson (Division Sign-Off) (Division Sign-of-Surgical, Orthopedic, Division orders and Restorative Devices K103712 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K103712](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K103712) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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