(167 days)
No
The summary describes a mechanical implant and its materials, manufacturing process, and performance testing. There is no mention of software, algorithms, data analysis, or any other indicators of AI/ML technology.
Yes
The device is an orthopedic implant designed to treat osteoarthritis in the shoulder, which is a therapeutic purpose.
No
Explanation: The device described is a shoulder implant system designed for surgical replacement of the humeral head in cases of osteoarthritis. Its intended use is therapeutic, involving physical implantation into the body for biological fixation, not the diagnosis of a disease or condition.
No
The device description clearly details physical implants (humeral head adapter, humeral implant, glenoid components, baseplate components) made through additive manufacturing with porous surfaces for biological fixation. The performance studies also focus on mechanical and material properties of these physical components. There is no mention of software as the primary or sole component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating osteoarthritis in the shoulder. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (humeral head adapter, stemless shoulder system) designed to be surgically placed within the patient's body. IVDs are typically reagents, instruments, or systems used to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is a medical device, specifically a surgical implant, used for treatment.
N/A
Intended Use / Indications for Use
Anatomic Total Shoulder Applications:
· Osteoarthritis
• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.
Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.
Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.
Product codes (comma separated list FDA assigned to the subject device)
PKC
Device Description
The OsseoFit™ Stemless Shoulder System consists of a stemless humeral head adapter for anatomic total shoulder applications. The OsseoFit humeral implant is an anatomical (left/right specific), asymmetric humeral anchor with six fins whose location, length, and height vary. The OsseoFit humeral implants are available in Onlay and Inlay variants. The Onlay implants sit on top of the prepared bone while the Inlay implants have a dished superior portion with a shorter fin length to sit within the bone. The OsseoFit Humeral Implant also includes anterior suture holes for soft tissue attachment.
The humeral implants are manufactured through additive manufacturing which includes areas of OsseoTi porous technology to allow biological fixation.
The OsseoFit Stemless Shoulder System is intended for cementless applications and is designed to be used with a compatible Identity Shoulder System (K213856) humeral head. The Identity Humeral Head is assembled to the OsseoFit Humeral Head Adapter via a locking taper by a disposable impactor that is packaged together with the head adapter. The Identity heads can be used with a compatible Alliance Glenoid Implant (K191814 and K193180) or Comprehensive Convertible Baseplate liner (K211729).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests
- Analysis of Potential Cortical Perforation
- · Construct Fatigue Testing
- · Corrosion Fatigue Testing
- Initial Fixation Evaluation in physiological loading condition: Micromotion testing
- · Initial Fixation Characterization: Pull out testing
- Initial Fixation Characterization: Lever out testing
- Initial Fixation Characterization: Torque out testing
- Static Tensile and Torsional Modular Junction Testing
- Range of Motion Analysis
- · Magnetic Resonance Imaging (MRI) Environment Compatibility Evaluation
- · Porous coating/metal characterization
- · Additive Manufacturing Process Validation Report
- Mechanical and chemical characterization of Additive Manufacturing
- Cleaning Validation
Conclusion
Non-clinical testing demonstrated that the new device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K213856, K191814, K193180, K211729
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
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.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2024
Zimmer, Inc. Alexandria Irwin Regulatory Affairs Sr Specialist 1800 W. Center Street Warsaw, Indiana 46850
Re: K241873
Trade/Device Name: OsseoFit Stemless Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: November 5, 2024 Received: November 5, 2024
Dear Alexandria Irwin:
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 (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"
1
(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
2
Sincerely,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2024.12.11 16:43:06 -05'00'
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
3
Indications for Use
Submission Number (if known)
Device Name
OsseoFit Stemless Shoulder System
Indications for Use (Describe)
Anatomic Total Shoulder Applications:
· Osteoarthritis
• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.
Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.
Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.
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)
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| K241873 | Page 1 of 3 | ||||
|---|---|---|---|---|---|
| 510(k) #: | K241873 | 510(k) Summary | Prepared on: 2024-12-11 | ||
| 21 CFR 807.92(a)(1) | |||||
| Contact Details | |||||
| Applicant Name | Zimmer, Inc. | ||||
| Applicant Address | 1800 W. Center Street Warsaw IN 46850 United States | ||||
| Applicant Contact Telephone | 1 574-373-0167 | ||||
| Applicant Contact | Mrs. Alexandria Irwin | ||||
| Applicant Contact Email | alexandria.irwin@zimmerbiomet.com | ||||
| 21 CFR 807.92(a)(2) | |||||
| Device Name | |||||
| Device Trade Name | OsseoFit Stemless Shoulder System | ||||
| Common Name | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem with No Diaphyseal Incursion, Semi-Constrained | ||||
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis | ||||
| Regulation Number | 888.3660 | ||||
| Product Code(s) | PKC | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K171858 | Sidus Stem-Free Shoulder | PKC | |||
| K182516 | Comprehensive Nano Stemless Shoulder | PKC | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The OsseoFit™ Stemless Shoulder System consists of a stemless humeral head adapter for anatomic total shoulder applications. The OsseoFit humeral implant is an anatomical (left/right specific), asymmetric humeral anchor with six fins whose location, length, and height vary. The OsseoFit humeral implants are available in Onlay and Inlay variants. The Onlay implants sit on top of the prepared bone while the Inlay implants have a dished superior portion with a shorter fin length to sit within the bone. The OsseoFit Humeral Implant also includes anterior suture holes for soft tissue attachment.
5
21 CFR 807.92(a)(5)
The humeral implants are manufactured through additive manufacturing which includes areas of OsseoTi porous technology to allow biological fixation.
The OsseoFit Stemless Shoulder System is intended for cementless applications and is designed to be used with a compatible ldentity Shoulder System (K213856) humeral head. The Identity Humeral Head is assembled to the OsseoFit Humeral Head Adapter via a locking taper by a disposable impactor that is packaged together with the head adapter. The ldentity heads can be used with a compatible Alliance Glenoid Implant (K191814 and K193180) or Comprehensive Convertible Baseplate liner (K211729).
Intended Use/Indications for Use
Anatomic Total Shoulder Applications:
· Osteoarthritis
• The patient must be anatomically suited, as evident by scapula and proximal humerus closure, to receive the implants.
OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.
Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.
Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.
Indications for Use Comparison
The subject device has the same intended use as the predicate device(s) and has the similar indications for use as the predicate(s). The OsseoFit Stemless Shoulder System narrowed the indications to Osteoarthritis.
Technological Comparison
The subject device has similar technological characteristics as the designated predicates. The rationale for substantial equivalence is based on consideration of the following characteristics:
• Intended Use: Identical to predicates
• Indications for Use: Similar to predicates
• Materials: Similar to predicates
· Design Features: Similar to predicates
• Packaging: Similar to predicates
· Sterilization: Identical to predicates
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-Clinical Tests
- Analysis of Potential Cortical Perforation
- · Construct Fatigue Testing
- · Corrosion Fatigue Testing
- Initial Fixation Evaluation in physiological loading condition: Micromotion testing
- · Initial Fixation Characterization: Pull out testing
- Initial Fixation Characterization: Lever out testing
- Initial Fixation Characterization: Torque out testing
- Static Tensile and Torsional Modular Junction Testing
- Range of Motion Analysis
- · Magnetic Resonance Imaging (MRI) Environment Compatibility Evaluation
- · Porous coating/metal characterization
- · Additive Manufacturing Process Validation Report
- Mechanical and chemical characterization of Additive Manufacturing
- Cleaning Validation
Clinical Tests None Provided
21 CFR 807.92(a)(5)
6
Conclusion
Non-clinical testing demonstrated that the new device is substantially equivalent to the predicate device.