Cleared Traditional

K103712 - GRYPHON PEEK DS ANCHOR W/ ORTHOCORD

K103712 is the FDA 510(k) clearance for GRYPHON PEEK DS ANCHOR W/ ORTHOCORD by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 554
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K103712.
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
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LOW PROFILE SCREWS
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TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
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K101165 · Wrightmedicaltechnologyinc · Jul 2010