(214 days)
No
The document describes a mechanical implant (humeral stem) and its materials and testing, with no mention of AI or ML in its function or design.
Yes
The device is a humeral stem component of a shoulder prosthesis system, indicated for replacement in conditions like severe pain or disability resulting from degenerative or traumatic disease of the glenohumeral joint. Its purpose is to alleviate symptoms and restore function, which aligns with the definition of a therapeutic device.
No
The device is a humeral stem component of a shoulder prosthesis system, which is an implant used for replacement in orthopedic surgery, not for diagnosing medical conditions.
No
The device description clearly states it is a humeral stem component of a shoulder prosthesis system, consisting of physical components like a stem, trunion, inclination block, pins, and screws made of titanium. This indicates a hardware device, not software only.
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 replacing a joint (glenohumeral joint) due to various conditions like degenerative disease, fractures, etc. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a humeral stem component of a shoulder prosthesis system, made of titanium. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Arthrex Univers Apex OptiFit Humeral Stem is indicated in replacement when conditions include severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; of the humeral head; or other difficult clinical management problems where arthrodesis or re-sectional arthroplasty is not acceptable.
The glenoid components are designed fixation in the joint and must only be used with an appropriate bone cement.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD
Device Description
The proposed Univers Apex OptiFit Humeral Stem is the humeral stem component of a shoulder prosthesis system. It consists of a stem, a trunion, an inclination block, pins, and screws. All the components are comprised of titanium with a titanium plasma spray (TPS) coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head
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)
Yield strength testing was performed on samples with and without titanium plasma spray coating (TPS). The acceptance criteria were met for all samples, demonstrating substantial equivalence. Additional computational electromagnetic simulation testing per FDA guidance, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," to assess RF heating in bone tissue demonstrated that the Arthrex Shoulder Systems are "MR Conditional."
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.
K131633: Arthrex Univers Apex
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.
K153115: Arthrex Univers Apex, Size 5 Stem, K172371: Arthrex Univers Reverse Coated Baseplate
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2023
Arthrex Inc Tiffanv Mentzel Principal Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K230513
Trade/Device Name: Arthrex Univers Apex OptiFit Humeral Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: August 30, 2023 Received: August 30, 2023
Dear Tiffany Mentzel:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely.
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2023.09.26
17:39:19-04'00'
Farzana Sharmin, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K230513
Device Name Arthrex Univers Apex OptiFit Humeral Stem
Indications for Use (Describe)
The Arthrex Univers Apex OptiFit Humeral Stem is indicated in replacement when conditions include severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; of the humeral head; or other difficult clinical management problems where arthrodesis or re-sectional arthroplasty is not acceptable.
The glenoid components are designed fixation in the joint and must only be used with an appropriate bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Date Prepared | September 22, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Tiffany Mentzel |
| Title: Principal Regulatory Affairs Specialist | |
| Phone: 1 (239) 643-5553 x 75833 | |
| Email: tiffany.mentzel@arthrex.com | |
| Trade Name | Arthrex Univers Apex OptiFit Humeral Stem |
| Common Name | Univers Apex OptiFit Humeral Stem |
| Product Code | KWS, HSD |
| Classification Name | 21 CFR 888.3660: Prosthesis, Shoulder, Semi- |
| Constrained, Metal/Polymer Cemented | |
| 21 CFR 888.3690: Prosthesis, Shoulder, Hemi-, | |
| Humeral, Metallic Uncemented | |
| Regulatory Class | II |
| Primary Predicate Device | K131633: Arthrex Univers Apex |
| Reference Devices | K153115: Arthrex Univers Apex, Size 5 Stem |
| K172371: Arthrex Univers Reverse Coated Baseplate | |
| Purpose of Submission | This Traditional 510(k) premarket notification is |
| submitted to obtain clearance for the Arthrex Univers | |
| Apex OptiFit Humeral Stem. | |
| Device Description | The proposed Univers Apex OptiFit Humeral Stem is |
| the humeral stem component of a shoulder prosthesis | |
| system. It consists of a stem, a trunion, an inclination | |
| block, pins, and screws. All the components are | |
| comprised of titanium with a titanium plasma spray | |
| (TPS) coating. | |
| Indications for Use | The Arthrex Univers Apex OptiFit Humeral Stem is |
| indicated in replacement when conditions include | |
| severe pain or significant disability resulting from | |
| degenerative, rheumatoid, traumatic disease, or injury | |
| of the glenohumeral joint; non-union humeral head | |
| fractures of long duration; irreducible 2- and 4- part | |
| proximal humeral fractures; avascular necrosis of the | |
| humeral head; or other difficult clinical management | |
| problems where arthrodesis or re-sectional arthroplasty | |
| is not acceptable. | |
| The glenoid components are designed for cemented | |
| fixation in the joint and must only be used with an | |
| appropriate bone cement. | |
| Performance Data | Yield strength testing was performed on samples with |
| and without titanium plasma spray coating (TPS). The | |
| acceptance criteria were met for all samples, | |
| demonstrating substantial equivalence. | |
4
| | Additional computational electromagnetic simulation
testing per FDA guidance, "Testing and Labeling
Medical Devices for Safety in the Magnetic Resonance
(MR) Environment," to assess RF heating in bone tissue
demonstrated that the Arthrex Shoulder Systems are
"MR Conditional." |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Comparison | The proposed device has the same technological
characteristics (material, sterilization method and
biocompatibility profile). The Arthrex Univers Apex
OptiFit Humeral Stem are substantially equivalent to the
predicate device in which the design features and
intended uses are the same. Any differences between
the proposed device and the predicate devices are
considered minor and do not result in new or different
questions concerning safety or effectiveness. |
| Conclusion | The Arthrex Univers Apex OptiFit Humeral Stem are
substantially equivalent to the predicate devices in
which the basic design features and intended use are
the same. Any differences between the proposed device
and the predicate devices are considered minor and do
not result in new or different questions concerning
safety or effectiveness. Based on the indications for
use, technological characteristics, and the summary of
data submitted, Arthrex has determined that the
proposed device is substantially equivalent to the
currently marketed predicate device. |