Cleared Traditional

K870867 - KM-4(TM) METAL-BACKED ACETABULAR CUP

K870867 is an FDA 510(k) clearance for KM-4(TM) METAL-BACKED ACETABULAR CUP, manufactured by Kirschner Medical Corp.. The device is a Class 3 Orthopedic device with product code JDL cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K870867 · Kirschner Medical Corp. · Orthopedic device
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May 1987
Decision
66d
Days
Class 3
Risk

K870867 is an FDA 510(k) clearance for the KM-4(TM) METAL-BACKED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on May 8, 1987 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3320 - 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: High-complexity regulatory submission. High regulatory complexity 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 - K870867

510(k) Number K870867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date May 08, 1987
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

JDL Device Classification - Class 3, Premarket Approval

Product Code JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3320
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

All 30
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K870867.
POROUS-COATED TITANIUM ACETABULAR CUP
K894965 · Dow Corning Wright · Nov 1989
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
K895607 · Exactech, Inc. · Nov 1989
PNEUMOTHORAX KIT, MOTIFICATION
K892640 · Arrow Intl., Inc. · Oct 1989
KM-3 ACETABULAR COMPONENT
K855042 · Kirschner Medical Corp. · Mar 1986
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
K854107 · Kirschner Medical Corp. · Mar 1986
MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
K850793 · Intermedics Orthopedics · May 1985