Cleared Traditional

HIP STEM SYSTEM TITANIUM ALLOY (K812801) - FDA 510(k) Clearance

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

K812801 · Osteonics Corp. · Orthopedic device
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Oct 1981
Decision
14d
Days
Class 2
Risk

K812801 is an FDA 510(k) clearance for the HIP STEM SYSTEM TITANIUM ALLOY. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1981 after a review of 14 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 K812801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date October 20, 1981
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
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 K812801.
TITANIUM AUFRANC-TURNER ATS HIP SYS
K821369 · Howmedica Corp. · May 1982
CONTOUR II LINK SP TOTAL HIP PROSTHESIS
K821066 · C.R. Bard, Inc. · Apr 1982
CEMENT RING
K813089 · Biomet, Inc. · Nov 1981
MIAMI, PROTRUSIO RING
K812182 · Zimmer, Inc. · Aug 1981
EFTEKHAR CENTRALIZING PLUG
K811293 · Zimmer, Inc. · Jun 1981
COLLARLESS TOTAL HIP FEMORAL COMP. SYS
K811151 · Howmedica Corp. · May 1981