# K250644: MSS - Monobloc stem - Pathway: 510(k) (Traditional) - Applicant: Medacta International S.A. - Decided: Feb 3, 2026 after 336 days - Product code: PHX (Shoulder Prosthesis, Reverse Configuration) - Device class: 2 - Regulation: 21 CFR 888.3660 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 17 generations back to K911686 (1991). 217 ancestors in all. 1 later device descends from it; 1 cites it directly. 1 of 219 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K170452: Medacta Shoulder System, Medacta International S.A. (2017) Summary page 7. - K223801: FX V135(TM) Shoulder Prosthesis, Fx Shoulder USA, Inc. (2023) Summary page 7. - K213117: FX V135 Shoulder Prosthesis, Fx Shoulder USA, Inc. (2022) Summary page 7. - K170910: Medacta Anatomic Shoulder Prosthesis, Medacta International S.A. (2017) Summary page 7. - K180089: Medacta Shoulder System Short Humeral Diaphysis, Medacta International S.A. (2018) Summary page 7. - K231911: Glenoid Reconstruction System – Full Wedge Baseplate, Medacta International S.A. (2023) Summary page 7. - K210207: Humeral Eccentric Reverse Metaphysis, Medacta International S.A. (2021) Summary page 7. - K212737: INHANCE™ Reverse Shoulder System, Depuy Ireland UC (2022) Summary page 7. - K130759: Humelock II Cementless Shoulder System, Fx Solutions (2013) Summary page 7. ## Most influential descendants - K261016: MSS - Humeral reverse liners extension (2026), 0 descendants of its own ## Recalls of this device - Apr 30, 2026 · Class II · Z-2618-2026: Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately ## Indications for use Reverse Shoulder Prosthesis The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation. The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation. Anatomic Shoulder Prosthesis The Medacta Anatomic Shoulder Prosthesis is intended for use as a hemi or total shoulder replacement for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use. The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use. Reverse Shoulder Prosthesis – monobloc stem The reverse shoulder prosthesis using the standard monobloc stem is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation. The reverse shoulder prosthesis using the short monobloc stem is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The short monobloc stem is intended for cementless use only. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation. Anatomic Shoulder Prosthesis – monobloc stem The anatomic shoulder prosthesis using the standard monobloc stem is intended for use as a hemi or total shoulder replacement. It is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used. The anatomic shoulder prosthesis using the short monobloc stem is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The short monobloc stem is intended for cementless use only. Source page: https://510kreport.com/device/K250644 Methodology: https://510kreport.com/methodology