Cleared Traditional

OSTEONICS HA-COATED DEVICES (K980070) - FDA 510(k) Clearance

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

K980070 · Osteonics Corp. · Orthopedic device
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Jul 1999
Decision
561d
Days
Class 2
Risk

K980070 is an FDA 510(k) clearance for the OSTEONICS HA-COATED DEVICES. 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 July 23, 1999 after a review of 561 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Osteonics Corp. devices

Submission Details

510(k) Number K980070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1998
Decision Date July 23, 1999
Days to Decision 561 days
Submission Type Traditional
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
439d slower than avg
Panel avg: 122d · This submission: 561d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K980070.
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
K993077 · Howmedica Osteonics Corp. · Oct 1999
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 PRIMARY SECUR-FIT PLUS HIP STEMS
K990203 · Osteonics Corp. · Feb 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