Cleared Traditional

K925607 - HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE

K925607 is an FDA 510(k) clearance for HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K925607 · Zimmer, Inc. · Orthopedic device
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Nov 1993
Decision
368d
Days
Class 2
Risk

K925607 is an FDA 510(k) clearance for the HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 8, 1993 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K925607

510(k) Number K925607 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 05, 1992
Decision Date November 08, 1993
Days to Decision 368 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 122d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 153
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K925607.
F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
K935990 · Implex Corp. · Jul 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K922621 · Smith & Nephew Richards, Inc. · Mar 1994
STABILITY FEMORAL PROSTHESIS W/HAP
K915655 · Depuy, Inc. · Feb 1994
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
K926299 · Depuy, Inc. · Oct 1993
H-220 PRESS-FIT ACETABULAR CUP SYSTEM
K926134 · Implex Corp. · Oct 1993
HYDROXYLAPATITE INFINITY(R)
K920969 · Dow Corning Wright · May 1993