Cleared Traditional

K911837 - SURETAC POLYGLYCONATE ABSORBABLE FIXATI...

K911837 is the FDA 510(k) clearance for SURETAC POLYGLYCONATE ABSORBABLE FIXATI... by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 97
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K911837.
ACUFEX(R) TAG(TM)
K911293 · Acufex Microsurgical, Inc. · Jul 1993
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
K924941 · Linvatec Corp. · Jun 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990
FIXATION STAPLE
K903022 · Onyx Medical Corp. · Aug 1990
ROUND STAPLE
K903271 · Onyx Medical Corp. · Jul 1990