Cleared Traditional

K890962 - ORTHOPAEDIC STAPLES

K890962 is an FDA 510(k) clearance for ORTHOPAEDIC STAPLES, manufactured by Ortho Spectrum, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K890962 · Ortho Spectrum, Inc. · Orthopedic device
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May 1989
Decision
77d
Days
Class 2
Risk

K890962 is an FDA 510(k) clearance for the ORTHOPAEDIC STAPLES. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Ortho Spectrum, Inc. (Fair Oaks, US). The FDA issued a Cleared decision on May 15, 1989 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 Ortho Spectrum, Inc. devices

FDA 510(k) Submission Details - K890962

510(k) Number K890962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date May 15, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 203
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K890962.
MITEK ANCHOR(TM)
K897155 · Mitek Surgical Products, Inc. · Apr 1990
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 (R) AMERICAN-TYPE BONE STAPLE SYSTEM
K873507 · Link America, Inc. · Sep 1987
LINK DYNAMIC STAPLE
K853704 · Link America, Inc. · Jan 1986