Cleared Traditional

K872856 - BIOPRO 32MM BALL

K872856 is the FDA 510(k) clearance for BIOPRO 32MM BALL by Biopro, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K872856 · Biopro, Inc. · Orthopedic device
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Aug 1987
Decision
27d
Days
Class 2
Risk

K872856 is an FDA 510(k) clearance for the BIOPRO 32MM BALL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on August 17, 1987 after a review of 27 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 Biopro, Inc. devices

Submission Details

510(k) Number K872856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1987
Decision Date August 17, 1987
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 448
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K872856.
POROUS COATED ACETABULAR CUP
K873585 · Johnson & Johnson Professionals, Inc. · Oct 1987
PREMIER-TOTAL (TM) HIP
K873999 · Intermedics Orthopedics · Oct 1987
MCCUTCHEN ACETABULAR CUP PROSTHESIS
K872732 · Dow Corning Wright · Oct 1987
MURRAY/WELCH TOTAL HIP SYSTEM
K871402 · Kirschner Medical Corp. · Jul 1987
HPS II CALCAR FEMORAL PROSTHESIS
K871857 · Depuy, Inc. · Jun 1987
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
K870235 · Osteonics Corp. · May 1987