Cleared Traditional

ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS (K874915) - FDA 510(k) Clearance

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

K874915 · Orthomet, Inc. · Orthopedic device
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Feb 1988
Decision
62d
Days
Class 2
Risk

K874915 is an FDA 510(k) clearance for the ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 3, 1988 after a review of 62 days - a notably fast clearance cycle.

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: 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 Orthomet, Inc. devices

Submission Details

510(k) Number K874915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1987
Decision Date February 03, 1988
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 52
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K874915.
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853 · Howmedica Corp. · May 1990
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · Depuy, Inc. · May 1989
HIP FRACTURE STEM SYSTEM
K883179 · Howmedica Corp. · Sep 1988
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
K872776 · Depuy, Inc. · Aug 1987
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
K872025 · Depuy, Inc. · Aug 1987
TRI-LOCK MODIFIED FEMORAL PROSTHESIS
K872878 · Depuy, Inc. · Aug 1987