Cleared Traditional

K910988 - OSTEONICS ION IMPLANTED FEMORAL BEARING...

K910988 is the FDA 510(k) clearance for OSTEONICS ION IMPLANTED FEMORAL BEARING... by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K910988 · Osteonics Corp. · Orthopedic device
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Mar 1991
Decision
19d
Days
Class 2
Risk

K910988 is an FDA 510(k) clearance for the OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES. 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 26, 1991 after a review of 19 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 K910988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date March 26, 1991
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K910988.
S-ROM OBLONG ACETABULAR CUP
K905258 · Joint Medical Products Corp. · May 1991
PS OMNIFIT NORMALIZED HIP STEM SERIES
K910662 · Osteonics Corp. · May 1991
OSTEONICS CDH HIP STEM
K910922 · Osteonics Corp. · Apr 1991
NEXUS ACETABULAR CUP
K905408 · Dow Corning Wright · Mar 1991
OSTEONICS(R) MPSS HIP STEM SERIES
K905275 · Osteonics Corp. · Jan 1991
C FIT CUP
K903938 · Orthopedic Systems, Inc. · Jan 1991