Cleared Traditional

K992891 - SYNTHES CERCLAGE POSITIONING PIN

K992891 is the FDA 510(k) clearance for SYNTHES CERCLAGE POSITIONING PIN by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K992891 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 1999
Decision
67d
Days
Class 2
Risk

K992891 is an FDA 510(k) clearance for the SYNTHES CERCLAGE POSITIONING PIN. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 2, 1999 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K992891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1999
Decision Date November 02, 1999
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 82
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K992891.
SPL CRIMP SYSTEM
K002110 · Pioneer Surgical Technology · Oct 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · Pioneer Surgical Technology · Aug 2000
PIONEER SILICOAT STERNAL CABLE
K993286 · Pioneer Surgical Technology · Nov 1999
SDB CERCLAGE SYSTEM
K992616 · Pioneer Surgical Technology · Oct 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · Howmedica Osteonics Corp. · Feb 1999
BMP CABLE SYSTEM
K982545 · Biomet, Inc. · Oct 1998