Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
Applicant
Biomet Orthopedics
Product Code
PHX · Orthopedic
Decision Date
Apr 15, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3660
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Biomet Comprehensive Reverse Shoulder Products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Biomet Comprehensive Reverse Shoulder Products is indicated for primary, fracture, or revision reverse total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty for patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the Ti6Al4V coating are indicated only for uncemented applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Humeral stem components are indicated for either cemented or uncemented biological fixation applications.
Device Story
Comprehensive Reverse Shoulder System (CRS) is a total shoulder replacement system in reverse configuration; includes humeral trays, bearings, glenospheres, taper adaptors, glenosphere baseplates, and various screws. Device replaces shoulder joint in patients with rotator cuff deficiency. Current notification covers manufacturing/material change for Standard and Mini Glenosphere Baseplates, specifically a new manufacturing site and new vendor for Hydroxyapatite (HA) coating application. No changes to other system components. Implants are surgically placed by orthopedic surgeons in clinical settings. HA-coated baseplates are intended for cementless application with screw fixation; humeral stems allow cemented or uncemented biological fixation. Titanium glenospheres are an alternative for patients with cobalt alloy sensitivity.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility assessment, shelf-life study, and characterization of the dual (HA/PPS) coating. Physicochemical, microstructure, and mechanical testing performed on devices and coupons post-gamma sterilization, utilizing NIST (SRM) 2910b control. Tests included elemental analysis, phase analysis, Ca/P ratio, FTIR, dissolution rate, microstructure, pore size, porosity, coating thickness, static tensile, and shear fatigue.
Technological Characteristics
Reverse shoulder prosthesis components. Baseplate substrate: Ti6Al4V. Coating: Dual HA/PPS (Hydroxyapatite over Porous Plasma Spray). Fixation: Cementless with screw fixation. Sterilization: Gamma. Testing performed per NIST (SRM) 2910b standards. No software or active energy source.
Indications for Use
Indicated for patients with grossly deficient rotator cuff and severe arthropathy or failed shoulder replacement. Requires functional deltoid muscle and suitable anatomy. Used for primary, fracture, or revision reverse total shoulder arthroplasty to relieve pain and disability. Titanium glenospheres for cobalt-sensitive patients; HA-coated glenoid components for uncemented use only.
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
April 15, 2026
Biomet Orthopedics
Julie Gantenberg
Regulatory Affairs Principal
56 E. Bell Drive
Warsaw, Indiana 46580
Re: K252404
Trade/Device Name: Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: PHX, KWS
Dated: July 31, 2025
Received: March 16, 2026
Dear Julie Gantenberg:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252404 - Julie Gantenberg
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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" (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-
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K252404 - Julie Gantenberg
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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).
Sincerely,
FARZANA SHARMIN -S
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252404 | |
| Device Name Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | |
| Indications for Use (Describe) | |
| Biomet Comprehensive Reverse Shoulder Products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Biomet Comprehensive Reverse Shoulder Products is indicated for primary, fracture, or revision reverse total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty for patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the Ti6Al4V coating are indicated only for uncemented applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Humeral stem components are indicated for either cemented or uncemented biological fixation applications. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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Page 1 of 2
| 510(k) #: K252404 | 510(k) Summary | Prepared on: 2026-03-16 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Biomet Orthopedics | |
| Applicant Address | 56 E. Bell Drive Warsaw IN 46580 United States | |
| Applicant Contact Telephone | 574-377-8133 | |
| Applicant Contact | Ms. Julie Gantenberg | |
| Applicant Contact Email | julie.gantenberg@zimmerbiomet.com | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | |
| 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 | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K193373 | Comprehensive Reverse Shoulder | PHX |
| K214001 | Comprehensive Shoulder System, Comprehensive Reverse Shoulder System | PHX |
| K080642 | Comprehensive Reverse Shoulder | PHX |
| K120121 | Comprehensive Reverse Shoulder - Mini Baseplate | PHX |
| K172502 | Comprehensive Augmented Glenoid Baseplate | PHX |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Comprehensive Reverse Shoulder System (CRS) is a total shoulder replacement system in a reverse configuration. The CRS system is composed of Humeral Trays, Humeral Bearings, Glenospheres, Taper Adaptor, Glenosphere Baseplate, Central Screws, Fixed Locking, Non-Locking, and Variable Locking Screws. The purpose of the current 510(k) notification is to make a change to the manufacturing/materials of the existing Standard and Mini Glenosphere Baseplate components, specifically moving to a different manufacturing site and proposing a different vendor for the application of the Hydroxyapatite (HA) coating. No changes are proposed to any of the other components of the system. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| Biomet Comprehensive Reverse Shoulder Products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. | | |
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Page 2 of 2
The Biomet Comprehensive Reverse Shoulder Products is indicated for primary, fracture, or revision reverse total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty for patients without material sensitivity to cobalt alloy.
Glenoid components with Hydroxyapatite (HA) coating applied over the Ti6Al4V coating are indicated only for uncemented applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
Humeral stem components are indicated for either cemented or uncemented biological fixation applications.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are identical to the primary predicate device.
## Technological Comparison
21 CFR 807.92(a)(6)
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicate device
- Indications for Use: Identical to predicate device
- Materials: Similar to the predicate
- Design Features: Identical to predicate device
- Packaging: Similar to predicate device
- Sterilization: Identical to reference device
Note: Regarding Materials, the baseplate substrate material is identical to the predicate. The subject HA Coating is similar to predicate. The underlying PPS Coating is identical to the reference device.
## Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
A Biocompatibility assessment, Shelf-life Study, and Characterization of the dual (HA/PPS) coating of the Comprehensive Glenosphere Baseplate components were conducted in support of substantial equivalence.
Characterization was performed on devices and coupons after final cleaning and gamma sterilization and met all applicable acceptance criteria.
Physicochemical, Microstructure, and Mechanical Testing analyses were done using the worst-case thickness and the NIST (SRM) 2910b control as recommended by the draft 2024 FDA guidance. Dual (HA/PPS) Coating characterization analyses included:
- Elemental analysis;
- Phase Analysis;
- Ca/P ratio analysis,
- Infrared analysis (FTIR);
- Dissolution rate;
- Microstructure
- Coating pore size
- Volume porosity
- Coating thickness
- Interconnecting porosity
- Static tensile;
- Shear fatigue;
The non-clinical testing demonstrates that the proposed coating of the Comprehensive Standard and Mini Glenosphere Baseplate components establish substantially equivalence to the predicate device.
