Cleared Traditional

K921525 - HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS

K921525 is an FDA 510(k) clearance for HIP JOINT METAL/POLYMER SEMI-CONSTRAINE..., manufactured by Implant Technology, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 1013-day FDA review.

K921525 · Implant Technology, Inc. · Orthopedic device
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Jan 1995
Decision
1013d
Days
Class 2
Risk

K921525 is an FDA 510(k) clearance for the HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Implant Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on January 11, 1995 after a review of 1013 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Implant Technology, Inc. devices

FDA 510(k) Submission Details - K921525

510(k) Number K921525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1992
Decision Date January 11, 1995
Days to Decision 1013 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
891d slower than avg
Panel avg: 122d · This submission: 1013d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 559
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K921525.
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K951301 · Depuy, Inc. · Apr 1995
ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
K951000 · Joint Medical Products Corp. · Apr 1995
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
K934515 · Zimmer, Inc. · Mar 1995
APOGEE HIP STEM WITH POROCOAT
K934334 · Depuy, Inc. · Dec 1994
ORTHOMET ACETABULAR CUP SYSTEM
K931333 · Orthomet, Inc. · Oct 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
K943054 · Osteonics Corp. · Oct 1994