Cleared Traditional

K881511 - FIXATOR PIN (EXTERNAL)

K881511 is an FDA 510(k) clearance for FIXATOR PIN (EXTERNAL), manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K881511 · Orthopedic Systems, Inc. · Orthopedic device
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Jun 1988
Decision
80d
Days
Class 2
Risk

K881511 is an FDA 510(k) clearance for the FIXATOR PIN (EXTERNAL). Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on June 30, 1988 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K881511

510(k) Number K881511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1988
Decision Date June 30, 1988
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JDW Pin, Fixation, Threaded

All 55
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K881511.
ORTHOPEDIC THREADED PIN FIXATION
K932349 · Osteomed Corp. · Mar 1994
RUSH PIN
K903261 · Onyx Medical Corp. · Jul 1990
STEINMAN PIN, THREAD
K903266 · Onyx Medical Corp. · Jul 1990
ACE/FISCHER PERCUTANEOUS HALF PINS
K875012 · Buckman Co., Inc. · Jan 1988
ACE PERCUTANEOUS 3MM HALF-PINS
K875013 · Buckman Co., Inc. · Jan 1988
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
K875022 · Buckman Co., Inc. · Jan 1988