Cleared Traditional

K915889 - MITEK BONE ANCHOR

K915889 is the FDA 510(k) clearance for MITEK BONE ANCHOR by Mitek Surgical Products, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 115
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