Cleared Special

OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (K990203) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K990203 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
28d
Days
Class 2
Risk

K990203 is an FDA 510(k) clearance for the OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on February 18, 1999 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Osteonics Corp. devices

Submission Details

510(k) Number K990203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1999
Decision Date February 18, 1999
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 102
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K990203.
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
K992025 · Howmedica Osteonics Corp. · Aug 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
K990666 · Smith & Nephew, Inc. · Aug 1999
OSTEONICS HA-COATED DEVICES
K980070 · Osteonics Corp. · Jul 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
K990197 · Exactech, Inc. · Feb 1999
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
K983382 · Osteonics Corp. · Dec 1998
OSTEONICS RESTORATION HA HIP STEMS
K983870 · Osteonics Corp. · Dec 1998