Cleared Traditional

OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES (K910988) - FDA 510(k) Clearance

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

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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K910988.
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
K910869 · Howmedica Corp. · May 1991
PS OMNIFIT NORMALIZED HIP STEM SERIES
K910662 · Osteonics Corp. · May 1991
OSTEONICS CDH HIP STEM
K910922 · Osteonics Corp. · Apr 1991
OSTEONICS(R) MPSS HIP STEM SERIES
K905275 · Osteonics Corp. · Jan 1991
OSTEONICS(R) 6011 HIP STEM SERIES
K905158 · Osteonics Corp. · Jan 1991
OSTEONICS HIP REVISION WEDGES
K905406 · Osteonics Corp. · Jan 1991