Orthopedic · 510(k) · 2026
Signature ONE System
Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared by FDA on 4 February 2026 under submission K260104, product code QHE (shoulder arthroplasty implantation system). What FDA's record says, in FDA's words.
Device record · K260104
- Device. Signature ONE SystemDEVICE
- Company. Orthosoft Inc. (d/b/a) Zimmer CAS (CA)COMPANY
- Decision. 4 February 2026, 510(k), substantially equivalent (special review); received 13 January 2026DECISION
- Panel. OrthopedicPANEL
- Product code. QHE, Shoulder Arthroplasty Implantation SystemCODE
- Regulation. 21 CFR 888.3660, Class IIREG
- Source. FDA database entry · decision document (10 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.
Please type in the marketing application/submission number, if it is known. This K260104 ? textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? Signature TM ONE System Please provide your Indications for Use below. ? The Signature TM ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature TM ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature ONE System. The Signature ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer Trabecular Metal Reverse Plus Shoulder, Comprehensive Total Shoulder System, Comprehensive Reverse Shoulder System, Comprehensive Reverse Augmented Baseplates and Alliance Glenoid System. The Signature TM ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications and contraindications: Comprehensive Total Shoulder System, Comprehensive Reverse Shoulder System, […]
The product code's definition, from FDA's classification record. Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
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.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 8 reports filed against devices carrying product code QHE. 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:
7 July 2026 · Malfunction · ARTHREXVIP WEB PORTAL · ARTHREX, INC. · report 1220246-2026-03626
IT WAS REPORTED THAT DURING A UNVERS REVERSE SHOULDER ARTHROPLASTY THE SURGEON DISCOVERED A DISCREPANCY BETWEEN THE PDF HAND-OUT AND THE WEB-BASED VIP PLANNING SOFTWARE. HE NOTICED THAT HE HAD PLANNED A 100% BACKSIDE SEATING AND WHEN HE OPENED THE PDF DURING THE SURGERY, HE REALIZED THAT THERE WAS SOMETHING DIFFERENT. HE DISCOVERED THAT THE STEM WAS DIFFERENT, THE SCREW LENGTHS WERE MISSING AND THE MARKING FOR THE AUGMENTED BASEPLATE HAD DISAPPEARED. AT THIS TIME, THE PATIENT WAS ALREADY UNDER […]
6 March 2026 · Malfunction · CORE SHOULDER SYSTEM · LINKBIO CORP. · report 3006721341-2026-00004
TWO CORE WORKSTATIONS IN INVENTORY WERE FOUND TO HAVE OUT-OF-SYNC TIME/DATE. AN ENGINEER LOGGED INTO THE SERVICE ACCOUNT FOR EACH WORKSTATION TO VIEW THE TIME AND DATE DISPLAYED ON THE TABLET'S CLOCK AND THEY WERE OBSERVED TO BE OUT-OF-SYNC BY SEVERAL MONTHS. AN ENGINEER THEN RE-SYNCED THESE WORKSTATIONS.
15 January 2025 · Malfunction · BLUEPRINT SOFTWARE · WRIGHT MEDICAL TECHNOLOGY INC · report 3000931034-2025-00037
AS REPORTED: "DR. (B)(6) IS GETTING AN ERROR WHEN HE TRIES TO LOAD THIS CASE. THE PATIENT WAS SUPPOSED TO HAVE SURGERY TODAY BUT HAS BEEN POSTPONED SINCE THEY CAN'T GET BP TO WORK.".
8 April 2024 · Malfunction · BLUEPRINT SOFTWARE · TORNIER S.A.S. · report 3000931034-2024-00196
AS REPORTED: "BLUEPRINT SOFTWARE ALLOWED USERS TO PLAN SURGERIES USING INCOMPATIBLE (NOT APPROVED) CONFIGURATIONS."
8 April 2024 · Malfunction · BLUEPRINT SOFTWARE · TORNIER S.A.S. · report 3000931034-2024-00198
AS REPORTED: "BLUEPRINT SOFTWARE ALLOWED USERS TO PLAN SURGERIES USING INCOMPATIBLE (NOT APPROVED) CONFIGURATIONS".
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 QHE, in Orthopedic, or cleared in 2026. 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.