Cleared Traditional

K951904 - SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]

K951904 is an FDA 510(k) clearance for SYNTHES (USA) [SYNTHES] POINT CONTACT F..., 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 84-day FDA review.

K951904 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
84d
Days
Class 2
Risk

K951904 is an FDA 510(k) clearance for the SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]. 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 July 17, 1995 after a review of 84 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K951904

510(k) Number K951904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date July 17, 1995
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K951904.
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SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
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