K261683 · Zimmer, Inc. · PHX · Jun 16, 2026 · Orthopedic
Device Facts
Record ID
K261683
Device Name
Augment Off-Axis Instrument System
Applicant
Zimmer, Inc.
Product Code
PHX · Orthopedic
Decision Date
Jun 16, 2026
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3660
Device Class
Class 2
Indications for Use
The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications. The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).
Device Story
Augment Off-Axis Instrument System comprises specialized reusable surgical instruments; designed for preparation of glenoid bone and tissue anatomy prior to implantation of Comprehensive Reverse Shoulder System or Alliance Augmented Glenoid System components. System provides alternate approach for ensuring proper preparation for glenoid implant augments in reverse and anatomic total shoulder arthroplasty. Instruments housed in drop-in tray for storage, sterilization, and transport. Used in clinical/surgical settings by orthopedic surgeons. Device represents minor design and labeling updates to previously cleared predicate (K241043) following complaint investigations.
Clinical Evidence
No clinical or non-clinical testing data was submitted to determine substantial equivalence; device relies on design similarity to the predicate.
Technological Characteristics
Reusable surgical instrument system; includes drop-in instrument tray for storage and sterilization. Materials, dimensions, and functional design are identical to predicate K241043. No energy source or software components.
Indications for Use
Indicated for adult patients undergoing reverse total shoulder arthroplasty or anatomic total shoulder arthroplasty requiring preparation of glenoid bone and tissue for implant augment placement; used with Comprehensive Reverse Shoulder System or Alliance Augmented Glenoid System.
Regulatory Classification
Identification
A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 16, 2026
Zimmer, Inc.
Eric Van Horn
Principal, Regulatory Affairs
1800 W. Center St.
Warsaw, Indiana 46580
Re: K261683
Trade/Device Name: Augment Off-Axis Instrument System
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: PHX, KWS, KWT
Dated: May 21, 2026
Received: May 21, 2026
Dear Eric Van Horn:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device'
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov
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K261683 - Eric Van Horn
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K261683 - Eric Van Horn
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Sincerely,
**Joseph P. Russell -S**
for: Farzana Sharmin, PhD
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K261683
?
Please provide the device trade name(s).
?
Augment Off-Axis Instrument System
Please provide your Indications for Use below.
?
The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications.
The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
?
Please select the age group(s) for which the device(s) is to be used.
☐ Neonates/Newborns (Birth to < 29 days old)
☐ Infants (29 days old to < 2 years old)
☐ Children (2 years old to < 12 years old)
☐ Adolescents (12 years old to < 22 years old)
☑ Adults (22 years old and greater)
?
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K261683 Pg. 1 of 3
510(k) #: K261683
# 510(k) Summary
Prepared on: 2026-05-21
## Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Zimmer,Inc. |
| --- | --- |
| Applicant Address | 1800 W Center Street Warsaw IN 46580 United States |
| Applicant Contact Telephone | 765-336-9090 |
| Applicant Contact | Mr. Eric Van Horn |
| Applicant Contact Email | eric.vanhorn@zimmerbiomet.com |
## Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Augment Off-Axis Instrument System |
| --- | --- |
| Common Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Classification Name | Shoulder Prosthesis, Reverse Configuration |
| Regulation Number | 888.3660 |
| Product Code(s) | PHX, KWS, KWT |
## Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K241043 | Augment Off-Axis Instrument System | PHX |
## Device Description Summary
21 CFR 807.92(a)(4)
There are no changes to the device description from the previously cleared Augment Off-Axis Instrument System predicate device (K241043). The Subject 510(k) describes minor changes to the design and labeling as a result of investigations into complaints. These changes are intended to be effected immediately upon submission acknowledgment.
The Augment Off-Axis Instrument System consists of specialized instruments that are designed for preparation of anatomy prior to implantation of Comprehensive® Reverse Shoulder System or Alliance® Augmented Glenoid System components. The instruments in this system are intended to provide an alternate approach in ensuring proper preparation of the glenoid bone and tissue for receipt of a glenoid implant augment in reverse and anatomic total shoulder arthroplasty procedures.
A drop-in instrument tray contains the Augment Off-Axis reusable surgical instruments for secure and ergonomic storage, sterilization, and transportation between uses.
## Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications.
The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).
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K261683 Pg 2 of 3
# Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject device indications for use are identical to the predicate device.
# Technological Comparison
21 CFR 807.92(a)(6)
The subject device is substantially equivalent to the predicate in design features, intended use, materials, dimensions, and function.
# Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
No Non-Clinical and/or Clinical Tests were submitted to determine the substantial equivalence of the subject device with the predicate.
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K261683 Pg. 3 of 3
# Verification
The following sections are complete:
- Application/Submission Type
- Cover Letter / Letters of Reference
- Administrative Information
- Device Description
- Indications for Use
- Classification
- Predicates and Substantial Equivalence
- Benefits, Risks, and Mitigation Measures
- Labeling
- Reprocessing, Sterility, and Shelf-Life
- Biocompatibility
- Software/Firmware, Cybersecurity, and Interoperability
- EMC, Wireless, Electrical, Mechanical, and Thermal Safety
- References
- Administrative Documentation
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## Registration and Listing
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.
Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee can be found at the Who Must Register, List and Pay the Fee website. There are no reductions in annual establishment registration fees for small businesses or any other group.
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE). The owner/operator cannot list the device until the premarket submission has been cleared, granted, or approved to market in the United States.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation's ability to prepare for and respond to public health emergencies.
For details about registering and listing your device, please see the Device Registration and Listing website. If you encounter an issue or wish to contact us regarding the Electronic Registration and Listing System known as the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM), please send an email to reglist@cdrh.fda.gov.
Augment Off-Axis Instrument System
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