Cleared Traditional

K926037 - HARPOON SUTURE ANCHOR

K926037 is an FDA 510(k) clearance for HARPOON SUTURE ANCHOR, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K926037 · Biomet, Inc. · Orthopedic device
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May 1993
Decision
155d
Days
Class 2
Risk

K926037 is an FDA 510(k) clearance for the HARPOON SUTURE ANCHOR. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 5, 1993 after a review of 155 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K926037

510(k) Number K926037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date May 05, 1993
Days to Decision 155 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 122d · This submission: 155d
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 124
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K926037.
MINVASIVE SUTURE BONE FASTENER
K924034 · Innovasive Devices, Inc. · Aug 1993
ACUFEX(R) TAG(TM)
K911293 · Acufex Microsurgical, Inc. · Jul 1993
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
K924941 · Linvatec Corp. · Jun 1993
QUICKANCHOR
K924665 · Mitek Surgical Products, Inc. · Oct 1992
MITEK BONE ANCHOR, MODIFICATION
K915889 · Mitek Surgical Products, Inc. · Oct 1992
QUICKANCHOR, MODIFICATION
K921873 · Mitek Surgical Products, Inc. · Jun 1992