Cleared Traditional

K911338 - LIMA CEMENT RESTRICTOR

K911338 is an FDA 510(k) clearance for LIMA CEMENT RESTRICTOR, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K911338 · Turnkey Intergration USA, Inc. · Orthopedic device
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Jun 1991
Decision
94d
Days
Class 2
Risk

K911338 is an FDA 510(k) clearance for the LIMA CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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 Turnkey Intergration USA, Inc. devices

FDA 510(k) Submission Details - K911338

510(k) Number K911338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date June 28, 1991
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDK Device Classification - Class 2, Special Controls

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - JDK Prosthesis, Hip, Cement Restrictor

All 34
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K911338.
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
BONE CEMENT RESTRICTOR
K926216 · Biodynamic Technologies, Inc. · Mar 1994
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · Osteonics Corp. · Oct 1992
OSTEONICS(R) MID-SHAFT CEMENT SPACER
K910461 · Osteonics Corp. · Apr 1991
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
K904746 · Joint Medical Products Corp. · Nov 1990
OSTEONICS CEMENT RESTRICTOR
K900462 · Osteonics Corp. · Mar 1990