(44 days)
The Healix BR and Gryphon BR Anchors are intended for:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
The Healix BR and Gryphon BR Anchors are absorbable threaded suture anchors manufactured of "Biocryl Rapide" material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Healix BR Anchor is provided in three sizes: one with an outer diameter of 4.5mm. another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The Gryphon BR Anchor is provided as size 3.0mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix BR and Gryphon BR Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.
1. Acceptance Criteria and Reported Device Performance:
The document provided does not specify explicit acceptance criteria for device performance based on quantitative metrics. Instead, the "Safety and Performance" section states: "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating substantial equivalence to pre-existing, legally marketed devices.
Therefore, the table would reflect this:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K071481, K070925, K071177, K032717, K060830) in terms of safety and performance for stated indications. | Demonstrated substantial equivalence to predicate devices based on performance and safety testing. |
2. Sample Size and Data Provenance:
The document does not provide details on the sample size used for any specific tests or studies. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing. The statement is general, referring to "performance and safety testing."
3. Number and Qualifications of Experts for Ground Truth:
This information is not provided in the document. The substantial equivalence claim is against predicate devices, not based on expert-established ground truth on a new dataset.
4. Adjudication Method:
This information is not provided in the document. As no specific "test set" with ground truth established by experts is mentioned, adjudication methods like 2+1 or 3+1 are not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The submission focuses on substantial equivalence to predicate devices rather than direct comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable as the device is a physical bone anchor, not an algorithm or AI-based system. Therefore, an "algorithm only" performance study would not be relevant.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically applied in AI/software evaluation (e.g., expert consensus, pathology, outcome data) is not directly relevant here. The "ground truth" in this context is implicitly the established safety and performance profile of the predicate devices to which this device is compared for substantial equivalence.
8. Sample Size for the Training Set:
This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."
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SECTION 2 – 510(k) SUMMARY
| Healix BR and Gryphon BR Anchor | JAN 17 200 | |
|---|---|---|
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 | |
| Contact Person | Ruth C. ForstadtProject Manager, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-977-3988Facsimile: 508-828-3750e-mail: rforstad@dpyus.jnj.com | |
| Name of Medical Device | Classification Name: | Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fasteners |
| Common/Usual Name: | Bone Anchor | |
| Proprietary Name: | Healix BR and Gryphon BR Anchor | |
| Substantial Equivalence | Healix BR and Gryphon BR Anchors are substantially equivalent to: | |
| Mitek Healix PEEK Anchor (K071481); BioKnotless/Lupine BRAnchors (K070925), the Arthrex Biocomposite Suture Anchor Family(K071177), and the Milagro Interference Screws (K032717 andK060830). | ||
| Device Classification | This device carries an FDA product code MAI, and subsequent productcodes GAM, GAS and GAT, and is classified as Single/Multiplecomponent metallic bone fixation appliances and fasteners under 21CFR 888.3030. | |
| Device Description | The Healix BR and Gryphon BR Anchors are absorbable threadedsuture anchors manufactured of "Biocryl Rapide" material. Thethreaded anchor comes preloaded on a disposable inserter assembly and | |
| is intended for fixation of #2 suture to bone. The Healix BR Anchor isprovided in three sizes: one with an outer diameter of 4.5mm. anotherwith an outer diameter of 5.5mm and the third with an outer diameter of6.5mm. The Gryphon BR Anchor is provided as size 3.0mm. Thesuture options may or may not include tapered needles to facilitatesuture passage through tissue. The Healix BR and Gryphon BRAnchors are currently offered with absorbable Panacryl, non-absorbableEthibond or partially absorbable Orthocord suture options. | ||
| Indications for Use | The Healix BR and Gryphon BR Anchors are intended for:Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair,Biceps Tenodesis, Acromio-Clavicular Separation Repair, DeltoidRepair, Capsular Shift or Capsulolabral Reconstruction;Foot/Ankle: Lateral Stabilization, Medial Stabilization, AchillesTendon Repair;Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;Elbow: Biceps Tendon Reattachment, Ulnar or Radial CollateralLigament Reconstruction. | |
| Safety and Performance | Results of performance and safety testing have demonstrated that themodified device is substantially equivalent to the predicate devices.Based on the indications for use, technological characteristics, andcomparison to predicate devices, the Healix BR and Gryphon BRAnchors have been shown to be substantially equivalent to predicatedevices under the Federal Food, Drug and Cosmetic Act. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.
JAN 1 7 2008
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitek, a Johnson & Johnson Company % Ruth C. Forstadt, RAC Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K073412
Trade/Device Name: Gryphon BR and Healix BR Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI Dated: January 10, 2008 Received: January 11, 2008
Dear Ms. Forstadt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ruth C. Forstadt, RAC
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K073412
Device Name: Gryphon BR Anchor
Gryphon BR Anchor is indicated for use in the following:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-the -Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oubare Mneen
Division of General, Restorative, and Neurological Devices
Number K073412
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510(k) Number (if known): K073412
Device Name: Healix BR Anchor
Healix BR Anchor is indicated for use in the following:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Prescription Use V (Part 21 CFR 801 Subpart D) OR
Over-the -Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Brielup
Division of General, Restorative. and Neurological Devices
510(k) Number. K07 3412
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.