Cleared Traditional

K971854 - OSTEOLOCK ACETABULAR SHELL SYSTEM

K971854 is the FDA 510(k) clearance for OSTEOLOCK ACETABULAR SHELL SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971854 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
71d
Days
Class 2
Risk

K971854 is an FDA 510(k) clearance for the OSTEOLOCK ACETABULAR SHELL SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 30, 1997 after a review of 71 days - a notably fast clearance cycle.

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: 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 Howmedica Corp. devices

Submission Details

510(k) Number K971854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date July 30, 1997
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 433
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K971854.
INFINTY DISTAL FEMORAL COMPONENT
K973530 · Wrightmedicaltechnologyinc · Oct 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
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DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
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K971429 · Wrightmedicaltechnologyinc · Jul 1997
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
K970300 · Intermedics Orthopedics · Jul 1997
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K964509 · Implex Corp. · Jun 1997