Cleared Traditional

EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP (K901297) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901297 · Exactech, Inc. · Orthopedic device
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May 1990
Decision
43d
Days
Class 2
Risk

K901297 is an FDA 510(k) clearance for the EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Exactech, Inc. devices

Submission Details

510(k) Number K901297 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 20, 1990
Decision Date May 02, 1990
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K901297.
HGP II TOTAL HIP FEMERAL STEM
K901364 · Zimmer, Inc. · May 1990
MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
K901087 · Depuy, Inc. · May 1990
MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.
K900832 · Depuy, Inc. · May 1990
MC2P ACETABULAR COMPONENT
K900438 · Osteonics Corp. · Apr 1990
OSTEONICS ECSI HIP STEM SERIES
K900836 · Osteonics Corp. · Mar 1990
MODIFIED AML + ACETABULAR CUP PROSTHESIS
K900891 · Depuy, Inc. · Mar 1990