Cleared Traditional

K873507 - LINK AMERICAN-TYPE BONE STAPLE SYSTEM

K873507 is an FDA 510(k) clearance for LINK AMERICAN-TYPE BONE STAPLE SYSTEM, manufactured by Link America, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K873507 · Link America, Inc. · Orthopedic device
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Sep 1987
Decision
16d
Days
Class 2
Risk

K873507 is an FDA 510(k) clearance for the LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Link America, Inc. (East Hanavor, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 16 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 Link America, Inc. devices

FDA 510(k) Submission Details - K873507

510(k) Number K873507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date September 16, 1987
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
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 140
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K873507.
MITEK ANCHOR
K892126 · Mitek Surgical Products, Inc. · Sep 1989
STAPLE FIXATION SYSTEM
K894929 · Concept, Inc. · Aug 1989
ORTHOMET ORTHOPEDIC STAPLES
K874914 · Orthomet, Inc. · Feb 1988
LINK DYNAMIC STAPLE
K853704 · Link America, Inc. · Jan 1986
KIRSCHNER BONE FIXATION FASTENER SYSTEM
K854445 · Kirschner Medical Corp. · Nov 1985
DAY STAPLE
K853267 · Protek, Inc. · Sep 1985