Cleared Traditional

K982996 - POLYMER OBL SB ANCHOR / SUTURE COMBINATION

K982996 is an FDA 510(k) clearance for POLYMER OBL SB ANCHOR / SUTURE COMBINATION, manufactured by Orthopaedic Biosystems, Ltd.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K982996 · Orthopaedic Biosystems, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
189d
Days
Class 2
Risk

K982996 is an FDA 510(k) clearance for the POLYMER OBL SB ANCHOR / SUTURE COMBINATION. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scottsdale, US). The FDA issued a Cleared decision on March 4, 1999 after a review of 189 days - an extended review 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: 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 Orthopaedic Biosystems, Ltd. devices

FDA 510(k) Submission Details - K982996

510(k) Number K982996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1998
Decision Date March 04, 1999
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 159
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K982996.
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