Cleared Traditional

K911837 - SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE

K911837 is an FDA 510(k) clearance for SURETAC POLYGLYCONATE ABSORBABLE FIXATI..., manufactured by Acufex Microsurgical, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K911837 · Acufex Microsurgical, Inc. · Orthopedic device
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Nov 1991
Decision
204d
Days
Class 2
Risk

K911837 is an FDA 510(k) clearance for the SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on November 15, 1991 after a review of 204 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 Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K911837

510(k) Number K911837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1991
Decision Date November 15, 1991
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 190
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K911837.
MITEK BONE ANCHOR, MODIFICATION
K915889 · 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
BIODEGRADABLE SURGICAL STAPLE
K910723 · Instrument Makar, Inc. · Mar 1991
SNAP-PAK (TM)
K905112 · Mitek Surgical Products, Inc. · Jan 1991
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990