Cleared Traditional

K915889 - MITEK BONE ANCHOR, MODIFICATION

K915889 is an FDA 510(k) clearance for MITEK BONE ANCHOR, manufactured by Mitek Surgical Products, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K915889 · Mitek Surgical Products, Inc. · Orthopedic device
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Oct 1992
Decision
307d
Days
Class 2
Risk

K915889 is an FDA 510(k) clearance for the MITEK BONE ANCHOR, MODIFICATION. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on October 22, 1992 after a review of 307 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Mitek Surgical Products, Inc. devices

FDA 510(k) Submission Details - K915889

510(k) Number K915889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date October 22, 1992
Days to Decision 307 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
185d slower than avg
Panel avg: 122d · This submission: 307d
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 197
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K915889.
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
K924941 · Linvatec Corp. · Jun 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
QUICKANCHOR
K924665 · Mitek Surgical Products, Inc. · Oct 1992
QUICKANCHOR, MODIFICATION
K921873 · Mitek Surgical Products, Inc. · Jun 1992
MITEK ANCHOR, MITEK ANCHOR II
K920213 · Mitek Surgical Products, Inc. · May 1992
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
K911837 · Acufex Microsurgical, Inc. · Nov 1991