Cleared Traditional

K072710 - NEXFIX COMPRESSION PIN

K072710 is an FDA 510(k) clearance for NEXFIX COMPRESSION PIN, manufactured by Nexa Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K072710 · Nexa Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2007
Decision
44d
Days
Class 2
Risk

K072710 is an FDA 510(k) clearance for the NEXFIX COMPRESSION PIN. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Nexa Orthopedics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 8, 2007 after a review of 44 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 Nexa Orthopedics, Inc. devices

FDA 510(k) Submission Details - K072710

510(k) Number K072710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2007
Decision Date November 08, 2007
Days to Decision 44 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 122d · This submission: 44d
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 69
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K072710.
TWISTCUT ENDOSORB SCREWS
K102777 · Merete Medical GmbH · Dec 2010
PROTOE ENDOSORB SMALL HAMMER TOE PIN
K100414 · Merete Medical GmbH · Jul 2010
ACUMED CLAVICLE SCREW SYSTEM
K083144 · Acumed, LLC · Jun 2009
SBI TITANIUM THREADED PIN
K071540 · Small Bone Innovations, Inc. · Aug 2007
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K061498 · Musculoskeletal Transplant Foundation · Jul 2006
TAPERED COMPRESSION PIN
K051740 · Nexa Orthopedics, Inc. · Sep 2005