Cleared Traditional

K112736 - PASS LP SPINAL

K112736 is an FDA 510(k) clearance for PASS LP SPINAL, manufactured by Medicrea International. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K112736 · Medicrea International · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
134d
Days
Class 2
Risk

K112736 is an FDA 510(k) clearance for the PASS LP SPINAL. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Medicrea International (Round Rock, US). The FDA issued a Cleared decision on February 1, 2012 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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.

FDA 510(k) Submission Details - K112736

510(k) Number K112736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date February 01, 2012
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 123
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K112736.
COMPRESSYN BAND
K130431 · Dallen Medical, Inc. · Jul 2013
JAZZ SYSTEM
K121541 · Implanet, S.A. · Sep 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · Spinal Elements, Inc. · Jul 2012
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE
K110541 · Figure 8 Surgical, Incorporated · Jul 2011
K2M COCR WIRE
K103797 · K2m, Inc. · May 2011