Cleared Traditional

K803126 - EXETER TOTAL HIP SYSTEM

K803126 is the FDA 510(k) clearance for EXETER TOTAL HIP SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K803126 · Howmedica Corp. · Orthopedic device
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Feb 1981
Decision
60d
Days
Class 2
Risk

K803126 is an FDA 510(k) clearance for the EXETER TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1981 after a review of 60 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 Howmedica Corp. devices

Submission Details

510(k) Number K803126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1980
Decision Date February 10, 1981
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 K803126.
MIAMI, PROTRUSIO RING
K812182 · Zimmer, Inc. · Aug 1981
EFTEKHAR CENTRALIZING PLUG
K811293 · Zimmer, Inc. · Jun 1981
COLLARLESS TOTAL HIP FEMORAL COMP. SYS
K811151 · Howmedica Corp. · May 1981
REINFORCED HIP CUP
K810120 · Biomet, Inc. · Feb 1981
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K802872 · Howmedica Corp. · Dec 1980
DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
K800894 · Depuy, Inc. · May 1980