Cleared Traditional

K904553 - BONE STAPLE(S)

K904553 is the FDA 510(k) clearance for BONE STAPLE(S) by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K904553 · Synthes (Usa) · Orthopedic device
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Dec 1990
Decision
77d
Days
Class 2
Risk

K904553 is an FDA 510(k) clearance for the BONE STAPLE(S). Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on December 21, 1990 after a review of 77 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.

View all Synthes (Usa) devices

Submission Details

510(k) Number K904553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1990
Decision Date December 21, 1990
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K904553.
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
K924941 · Linvatec Corp. · Jun 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
K911837 · Acufex Microsurgical, Inc. · Nov 1991
FIXATION STAPLE
K903022 · Onyx Medical Corp. · Aug 1990
ROUND STAPLE
K903271 · Onyx Medical Corp. · Jul 1990
BARBED SQUARE STAPLE
K903273 · Onyx Medical Corp. · Jul 1990