Cleared Traditional

K111970 - KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT

K111970 is an FDA 510(k) clearance for KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code KRR cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K111970 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
227d
Days
Class 2
Risk

K111970 is an FDA 510(k) clearance for the KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on February 23, 2012 after a review of 227 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - 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 Tornier devices

FDA 510(k) Submission Details - K111970

510(k) Number K111970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2011
Decision Date February 23, 2012
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRR Device Classification - Class 2, Special Controls

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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 - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 24
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K111970.
Arthrex iBalance BiCompartmental Arthroplasty System
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K123907 · Biomet Manufacturing Corp · Sep 2013
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
K082088 · Mako Surgical Corp. · Oct 2008
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM
K080029 · Mako Surgical Corp. · May 2008
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
K071413 · Arthrosurface, Inc. · Nov 2007