Cleared Traditional

K923613 - SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT

K923613 is an FDA 510(k) clearance for SYNTHES LIMITED CONTACT-DYNAMIC HIP SCR..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K923613

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.

JDO Device Classification - Class 2, Special Controls

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 22
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