Cleared Traditional

MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS (K870216) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870216 · Osteonics Corp. · Orthopedic device
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Mar 1987
Decision
59d
Days
Class 2
Risk

K870216 is an FDA 510(k) clearance for the MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 59 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 Osteonics Corp. devices

Submission Details

510(k) Number K870216 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 20, 1987
Decision Date March 20, 1987
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K870216.
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
K870235 · Osteonics Corp. · May 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · Depuy, Inc. · May 1987
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
K870699 · Depuy, Inc. · May 1987
THREADED ACETABULAR COMPONENT
K870445 · Johnson & Johnson Professionals, Inc. · Mar 1987
AML II TITANIUM ACETABULUM PROSTHESIS
K861979 · Depuy, Inc. · Jan 1987
PROFILE HIP ACETABULUM PROSTHESIS
K863184 · Depuy, Inc. · Jan 1987