Cleared Traditional

K951517 - OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES

K951517 is an FDA 510(k) clearance for OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K951517 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
289d
Days
Class 2
Risk

K951517 is an FDA 510(k) clearance for the OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES. 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 January 17, 1996 after a review of 289 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonics Corp. devices

FDA 510(k) Submission Details - K951517

510(k) Number K951517 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 03, 1995
Decision Date January 17, 1996
Days to Decision 289 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
167d slower than avg
Panel avg: 122d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K951517.
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
K963959 · Osteonics Corp. · Dec 1996
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
K954800 · Intermedics Orthopedics · Apr 1996
PCA +15MM MODULAR FEMORAL HEAD
K955305 · Howmedica Corp. · Jan 1996
OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM
K954023 · Osteonics Corp. · Nov 1995
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
K951671 · Osteonics Corp. · Sep 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K951932 · Osteonics Corp. · Sep 1995