Cleared Special

K121263 - TAPER SET HIP SYSTEM RDP STEM

K121263 is an FDA 510(k) clearance for TAPER SET HIP SYSTEM RDP STEM, manufactured by Consensus Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 26-day FDA review.

K121263 · Consensus Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
26d
Days
Class 2
Risk

K121263 is an FDA 510(k) clearance for the TAPER SET HIP SYSTEM RDP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Consensus Orthopedics, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on May 22, 2012 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Consensus Orthopedics, Inc. devices

FDA 510(k) Submission Details - K121263

510(k) Number K121263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2012
Decision Date May 22, 2012
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 477
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K121263.
HIP SYSTEMS
K121308 · Howmedica Osteonics Corp. · Jul 2012
U2 ACETABULAR CUP, PLASMA SPRAY
K121777 · United Orthopedic Corp. · Jul 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
K121024 · Encore Medical, L.P. · Jun 2012
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
K112158 · Lima Corporate S.P.A. · May 2012
LINEAR HIP STEM, SIZE 5
K120241 · Encore Medical, L.P. · Feb 2012
APEX ARC HIP STEM
K113242 · Omni Life Science, Inc. · Jan 2012