Cleared Traditional

K844319 - KM-2 METAL-BACKED ACETABULAR CUP

K844319 is an FDA 510(k) clearance for KM-2 METAL-BACKED ACETABULAR CUP, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K844319 · Kirschner Medical Corp. · Orthopedic device
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Sep 1985
Decision
317d
Days
Class 2
Risk

K844319 is an FDA 510(k) clearance for the KM-2 METAL-BACKED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Plymouth, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K844319

510(k) Number K844319 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 06, 1984
Decision Date September 19, 1985
Days to Decision 317 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
195d slower than avg
Panel avg: 122d · This submission: 317d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K844319.
CONICAL COLLAR HIP PROSTHESIS
K854046 · Kirschner Medical Corp. · Nov 1985
COLLAR LESS AML HIP
K853408 · Depuy, Inc. · Nov 1985
GT HIP PROSTHESIS FEMORAL COMPONENT
K853169 · Intermedics Orthopedics · Oct 1985
NEW JERSEY MODULAR FEMORAL HIP
K853655 · Depuy, Inc. · Sep 1985
S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP
K851422 · Joint Medical Products Corp. · Sep 1985
POROUS APF/MODULAR FEMORAL COMPONENT
K852585 · Biomet, Inc. · Aug 1985