Cleared Traditional

K942889 - SB ANCHOR

K942889 is an FDA 510(k) clearance for SB ANCHOR, 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 431-day FDA review.

K942889 · Orthopaedic Biosystems, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
431d
Days
Class 2
Risk

K942889 is an FDA 510(k) clearance for the SB ANCHOR. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scotsdale, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Orthopaedic Biosystems, Ltd. devices

FDA 510(k) Submission Details - K942889

510(k) Number K942889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date August 25, 1995
Days to Decision 431 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 122d · This submission: 431d
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 160
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K942889.
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LMT BONE ANCHOR
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ETHICON NONABSORBABLE SUTURE ANCHOR
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MITEK TOGGLE ANCHOR(TM)
K950070 · Mitek Surgical Products, Inc. · May 1995