Cleared Traditional

K881983 - HOWMEDICA PRECISION OSTEOLOCK FEMORAL C...

K881983 is the FDA 510(k) clearance for HOWMEDICA PRECISION OSTEOLOCK FEMORAL C... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LWJ) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K881983 · Howmedica Corp. · Orthopedic device
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Oct 1988
Decision
147d
Days
Class 2
Risk

K881983 is an FDA 510(k) clearance for the HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K881983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date October 06, 1988
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 55
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K881983.
KDG ACETABULAR COMPONENT
K891262 · Osteonics Corp. · Jun 1989
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661 · Depuy, Inc. · Feb 1989
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · Osteonics Corp. · Oct 1988
CORIN MODULAR MOORE STEM
K881288 · Orthopedic Systems, Inc. · Jun 1988
TI-FIT TOTAL HIP SYSTEM
K873797 · Richards Medical Co., Inc. · Nov 1987
MICRO-STRUCTURED HS2P HIP STEMS
K833970 · Osteonics Corp. · Jan 1984