Orthopedic · 510(k) · 2025
MyShoulder Planner (5.3SSWPL)
Medacta International S.A.. Cleared by FDA on 30 January 2025 under submission K241292, product code KWS (prosthesis, shoulder, semi-constrained, metal/polymer cemented). What FDA's record says, in FDA's words.
Device record · K241292
- Device. MyShoulder Planner (5.3SSWPL)DEVICE
- Company. Medacta International S.A. (CH)COMPANY
- Decision. 30 January 2025, 510(k), substantially equivalent (traditional review); received 8 May 2024DECISION
- Panel. OrthopedicPANEL
- Product code. KWS, Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedCODE
- Regulation. 21 CFR 888.3660, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals. The MyShoulder Planner software is specifically designed to support the planning of the humeral and glenoid components in a total shoulder replacement using Medacta Shoulder System prosthesis. The MyShoulder Planner software should not be used for diagnostic purposes. The MyShoulder Planner software processes CT scan images in DICOM format to allow surgeons to visualize, measure, and reconstruct anatomic data. These features enable surgeons to make decisions on implant size and positioning, including the ability to annotate anatomical structures. The MyShoulder Planner software leads to the generation of patient-specific planning reports, which summarize the preliminary decisions regarding implant size and positioning. The MyShoulder Planner software allows the surgeons to request the MyShoulder patient matched guides according to the pre-surgical plan.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 23,763 reports filed against devices carrying product code KWS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Injury · DJO SURGICAL · Encore Medical L.P · report 1644408-2026-02027
30 September 2026 · Injury · SMR Shoulder · Limacorporate S.p.A · report 3008021110-2026-00362
Revision surgery has been performed on (b)(6) 2026 due to glenoid baseplate loosening.Previous surgery is unknow, as well as complete product information of original implant. During revision the whole glenoid assembly has been removed, as well as the humeral reverse liner, and the construct has been converted to a hemi arthroplasty with an Adaptor 36mm for Reverse Body (code 1352.15.200) and CTA head Dia54 (code 1323.09.540).Surgery was completed as intended.Patient if female, date of birth […]
30 September 2026 · Injury · GLOBAL · DePuy Orthopaedics Inc US · report 1818910-2026-16857
It was reported that patient had left anatomic total shoulder approximately 10 years ago. Original date of surgery and hospital are unknown. Patient developed rotator cuff arthropathy and was revised to a reverse total shoulder.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Left shoulder.
30 September 2026 · Injury · Unknown Tornier Perform Augmented Glenoid · Tornier Inc · report 0001649390-2026-01021
30 September 2026 · Injury · Unknown Tornier Perform Baseplate · Tornier Inc · report 0001649390-2026-01023
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code KWS, in Orthopedic, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.