Cleared Traditional

K923613 - SYNTHES LIMITED CONTACT-DYNAMIC HIP SCR...

K923613 is the FDA 510(k) clearance for SYNTHES LIMITED CONTACT-DYNAMIC HIP SCR... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDO) cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K923613 · Synthes (Usa) · Orthopedic device
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Jun 1993
Decision
336d
Days
Class 2
Risk

K923613 is an FDA 510(k) clearance for the SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT. Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

Submission Details

510(k) Number K923613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date June 22, 1993
Days to Decision 336 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
214d slower than avg
Panel avg: 122d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDO Device, Fixation, Proximal Femoral, Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDO Device, Fixation, Proximal Femoral, Implant

All 17
Devices cleared under the same product code (JDO) and FDA review panel - the closest regulatory comparables to K923613.
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]
K951904 · Synthes (Usa) · Jul 1995
PROFORM HIP SYSTEM
K934161 · Stelkast Company · Mar 1994
PROFORM HA HIP SYSTEM
K934162 · Stelkast Company · Mar 1994
COMPRESSION SYSTEM
K831076 · Kirschner Medical Corp. · Apr 1983
PROXIMAL FERMORAL HIP REPLACEMENT
K810258 · Biomet, Inc. · Mar 1981
BIOMET CONCENTRIC HEX SCREW
K781389 · Biomet, Inc. · Aug 1978