Cleared Traditional

K103712 - GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD

K103712 is an FDA 510(k) clearance for GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, manufactured by Depuy Mitek, A Johnson & Johnson Company. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K103712 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
81d
Days
Class 2
Risk

K103712 is an FDA 510(k) clearance for the GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on March 11, 2011 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Mitek, A Johnson & Johnson Company devices

FDA 510(k) Submission Details - K103712

510(k) Number K103712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2010
Decision Date March 11, 2011
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K103712.
LATARJET CORTICAL SCREW SET
K110763 · T.A.G. Medical Products Corporation, Ltd. · Apr 2011
LOW PROFILE SCREWS
K103705 · Arthrex, Inc. · Mar 2011
FLEXFUSION (TM) FIXATION IMPLANT
K110445 · Nextremity Solutions, LLC · Mar 2011
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
K102298 · Depuy Mitek, A Johnson & Johnson Company · Jan 2011
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
K102410 · Conmed Linvatec · Dec 2010
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
K102326 · Parcus Medical, LLC · Nov 2010