Cleared Traditional

K082215 - OSTEORAPTOR SUTURE ANCHOR

K082215 is an FDA 510(k) clearance for OSTEORAPTOR SUTURE ANCHOR, manufactured by Smith & Nephew Inc., Endoscopy Division. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K082215 · Smith & Nephew Inc., Endoscopy Division · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
89d
Days
Class 2
Risk

K082215 is an FDA 510(k) clearance for the OSTEORAPTOR SUTURE ANCHOR. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Smith & Nephew Inc., Endoscopy Division (Andover, US). The FDA issued a Cleared decision on November 3, 2008 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

FDA 510(k) Submission Details - K082215

510(k) Number K082215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date November 03, 2008
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 232
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K082215.
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
K102387 · Mediscope Manufacturing, Inc. · Oct 2011
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
K102143 · Suspension Orthopaedic Solutions, LLC · Dec 2010
OSSTAPLE CHILL
K102107 · Biomedical Ent., Inc. · Sep 2010
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008
ENDOBUTTON CONTINUOUS LOOP (CL)
K081098 · Smith & Nephew Inc., Endoscopy Division · Jul 2008
CAIS STAPLE
K073281 · Depuy Mitek, A Johnson & Johnson Company · May 2008
K082215 · OSTEORAPTOR SUTURE ANCHOR
Download PDF FDA Summary Smith & Nephew Inc., …