Cleared Traditional

K902712 - OSTEONICS PS HEAD AND NECK HIP STEM SERIES

K902712 is the FDA 510(k) clearance for OSTEONICS PS HEAD AND NECK HIP STEM SERIES by Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K902712 · Osteonics Corp. · Orthopedic device
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Aug 1990
Decision
50d
Days
Class 2
Risk

K902712 is an FDA 510(k) clearance for the OSTEONICS PS HEAD AND NECK HIP STEM SERIES. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 50 days - a notably fast clearance cycle.

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: 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 Osteonics Corp. devices

Submission Details

510(k) Number K902712 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 20, 1990
Decision Date August 09, 1990
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K902712.
TOTAL HIP FEMORAL COMPONENT
K905260 · Intermedics Orthopedics · Jan 1991
DCW MODULAR PROXIMAL FEMORAL SYSTEM
K904028 · Dow Corning Wright · Jan 1991
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
K903976 · Kinamed, Inc. · Jan 1991
KINAMED CEMENTED ATH-LONG STEM
K902073 · Kinamed, Inc. · Jun 1990
KINAMED CEMENTED CTH STEM
K902074 · Kinamed, Inc. · Jun 1990
MODULAR HIP SYSTEM
K900628 · Richards Medical Co., Inc. · May 1990