Cleared Traditional

K952970 - HOWMEDICA FEMORAL & PROXIMAL TIBIAL MOD...

K952970 is the FDA 510(k) clearance for HOWMEDICA FEMORAL & PROXIMAL TIBIAL MOD... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K952970 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
204d
Days
Class 2
Risk

K952970 is an FDA 510(k) clearance for the HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Howmedica Corp. devices

Submission Details

510(k) Number K952970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1995
Decision Date January 17, 1996
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K952970.
P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT
K953202 · Johnson & Johnson Professionals, Inc. · Jan 1996
ALTERNATIVE STERILIZATION PROCESS
K955354 · Howmedica Corp. · Jan 1996
ZCH ALPHA SYSTEM
K954744 · Zimmer, Inc. · Jan 1996
BETA FEMORAL HIP STEM
K945774 · Wrightmedicaltechnologyinc · Dec 1995
APR ACETABULAR INSERTS IOI BIPOLAR
K935585 · Intermedics Orthopedics · Dec 1995
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K951139 · Wrightmedicaltechnologyinc · Nov 1995