Cleared Traditional

K850352 - MICRO-STRUC. ACETABULAR COMPON- MC2P

K850352 is the FDA 510(k) clearance for MICRO-STRUC. ACETABULAR COMPON- MC2P by Osteonics Corp.. It is a Class 3 Orthopedic device (product code JDL) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K850352 · Osteonics Corp. · Orthopedic device
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Apr 1985
Decision
87d
Days
Class 3
Risk

K850352 is an FDA 510(k) clearance for the MICRO-STRUC. ACETABULAR COMPON- MC2P. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 25, 1985 after a review of 87 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 Osteonics Corp. devices

Submission Details

510(k) Number K850352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date April 25, 1985
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K850352.
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
101-32 FEMORAL COMPONENT
K813599 · Intermedics Orthopedics · Jan 1982
BG PROXIMAL FEMUR
K790274 · Howmedica Corp. · Mar 1979
PROSTHESIS, VIDAL TOTAL HIP
K770472 · Howmedica Corp. · Mar 1977