Cleared Special

K022711 - MODIFICATION TO AVALON CUP SYSTEM

K022711 is an FDA 510(k) clearance for MODIFICATION TO AVALON CUP SYSTEM, manufactured by Orthopedic Source, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 12-day FDA review.

K022711 · Orthopedic Source, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
12d
Days
Class 2
Risk

K022711 is an FDA 510(k) clearance for the MODIFICATION TO AVALON CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Orthopedic Source, Inc. (Loomis, US). The FDA issued a Cleared decision on August 26, 2002 after a review of 12 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.

FDA 510(k) Submission Details - K022711

510(k) Number K022711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2002
Decision Date August 26, 2002
Days to Decision 12 days
Submission Type Special
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
110d faster than avg
Panel avg: 122d · This submission: 12d
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 564
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K022711.
SMITH & NEPHEW HIP SYSTEM
K022902 · Smith & Nephew, Inc. · Oct 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · Zimmer, Inc. · Sep 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · Smith & Nephew, Inc. · Aug 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
K022463 · Biomet Orthopedics, Inc. · Aug 2002
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070 · Zimmer, Inc. · Jul 2002
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
K021466 · Hayes Medical, Inc. · Jul 2002
K022711 · MODIFICATION TO AVALON CUP SYSTEM
Download PDF FDA Summary Orthopedic Source, In…