Cleared Traditional

K883941 - PROFORMA HIP SYSTEM

K883941 is an FDA 510(k) clearance for PROFORMA HIP SYSTEM, 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 72-day FDA review.

K883941 · Orthomet, Inc. · Orthopedic device
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Nov 1988
Decision
72d
Days
Class 2
Risk

K883941 is an FDA 510(k) clearance for the PROFORMA HIP SYSTEM. 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 November 30, 1988 after a review of 72 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 - K883941

510(k) Number K883941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1988
Decision Date November 30, 1988
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K883941.
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
K890054 · Protek, Inc. · Feb 1989
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
K884888 · Protek, Inc. · Dec 1988
PERFECTA II TOTAL HIP SYSTEM
K883618 · Orthomet, Inc. · Dec 1988
MODULAR COLLARED HJD TOTAL HIP SYSTEM
K884457 · Richards Medical Co., Inc. · Nov 1988
GEMINI FEMORAL HIP PROSTHESIS
K883724 · Depuy, Inc. · Nov 1988
TOWNLEY COX COMB ACETABULAR COMPONENT
K882869 · Biopro, Inc. · Oct 1988