Cleared Traditional

K071413 - HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM

K071413 is an FDA 510(k) clearance for HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM, manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code KRR cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K071413 · Arthrosurface, Inc. · Orthopedic device
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Nov 2007
Decision
172d
Days
Class 2
Risk

K071413 is an FDA 510(k) clearance for the HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 172 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 Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K071413

510(k) Number K071413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date November 09, 2007
Days to Decision 172 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
50d slower than avg
Panel avg: 122d · This submission: 172d
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 23
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K071413.
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
K111970 · Tornier · Feb 2012
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
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
K070695 · Zimmer, Inc. · Jun 2007
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
K060127 · Arthrosurface, Inc. · Mar 2006
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948 · Howmedica Osteonics Corp. · Oct 2005