Cleared Traditional

K130550 - RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW

K130550 is an FDA 510(k) clearance for RSP MODULAR GLENOID BASEPLATE, manufactured by Encore Medical, L.P.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K130550 · Encore Medical, L.P. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2014
Decision
385d
Days
Class 2
Risk

K130550 is an FDA 510(k) clearance for the RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on March 24, 2014 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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. Elevated predicate reliance profile. 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 Encore Medical, L.P. devices

FDA 510(k) Submission Details - K130550

510(k) Number K130550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date March 24, 2014
Days to Decision 385 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
263d slower than avg
Panel avg: 122d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PHX Device Classification - Class 2, Special Controls

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
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 - PHX Shoulder Prosthesis, Reverse Configuration

All 202
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K130550.
RSP HUMERAL SOCKET INSERT
K141006 · Djo Global · Jun 2014
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K133378 · Zimmer, Inc. · May 2014
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
K140904 · Encore Medical, L.P. · May 2014
REUNION RSA SHOULDER SYSTEM
K130895 · Howmedica Osteonics Corp. · Dec 2013
AEQUALIS REVERSED SHOULDER PROSTHESIS
K132285 · Tornier S.A.S. · Dec 2013
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
K131231 · Tornier S.A.S. · Oct 2013