Cleared Traditional

K901328 - DOMED AND FINNED ACETABULAR COMPONENT

K901328 is an FDA 510(k) clearance for DOMED AND FINNED ACETABULAR COMPONENT, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K901328 · Orthomet, Inc. · Orthopedic device
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May 1990
Decision
62d
Days
Class 2
Risk

K901328 is an FDA 510(k) clearance for the DOMED AND FINNED ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 22, 1990 after a review of 62 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K901328

510(k) Number K901328 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 21, 1990
Decision Date May 22, 1990
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K901328.
KM-5 METAL BACKED ACETABULAR CUP
K902279 · Kirschner Medical Corp. · Aug 1990
ACETABULAR CUP
K903242 · Onyx Medical Corp. · Jul 1990
MULLER-TYPE FEMORAL COMPONENT
K903243 · Onyx Medical Corp. · Jul 1990
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