(40 days)
Not Found
No
The summary describes a mechanical elbow prosthesis and its components. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are based on mechanical testing.
Yes
The device is an elbow prosthesis intended to treat conditions like joint destruction, degenerative diseases, arthritis, fractures, and deformities, which are all therapeutic interventions aimed at alleviating symptoms and restoring function.
No
The TEMA Elbow system is a cemented total elbow prosthesis intended for use in treating various conditions compromising elbow joint function, such as severe joint destruction, arthritis, fractures, and deformities. It is a prosthetic device designed for surgical implantation to restore joint function rather than to diagnose medical conditions.
No
The device description clearly outlines physical components made of metallic and polyethylene materials, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating elbow joint conditions. This involves direct intervention within the body.
- Device Description: The device is a total elbow prosthesis, a physical implant designed to replace or support the elbow joint.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:
-
- Elbow joint destruction which significantly compromises the activities of daily living
-
- Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
-
- Rheumatoid arthritis or degenerative arthritis with incapacitating pain
-
- Revision where other devices or treatments have failed.
-
- Correction of severe functional deformity.
-
- Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
-
- Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of disengagement between ulnar and humeral components, when intraoperative manual testing is performed.
Product codes (comma separated list FDA assigned to the subject device)
JDB, JDC
Device Description
TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.
TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.
The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.
The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.
TEMA Elbow system - Line extension introduces two new sizes of Ulnar stems to the ulnar stem range already cleared; moreover, a design change is introduced for the axle component, ulnar body component and for the humeral body compared to the original cleared version.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow joint
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 testing, specifically mechanical evaluations (both bench tests and rationales), demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:
- Range of motion
- Stability, fatigue and fretting-corrosion evaluation post-fatigue of modular connections
- Wear evaluation
Clinical testing was not necessary.
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.
Not Found
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
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
October 26, 2022
Image /page/0/Picture/1 description: The image contains 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.
LimaCorporate S.p.A. % Kenneth Newman Regulatory Affairs Associate Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington. Texas 76006
Re: K222807
Trade/Device Name: TEMA Elbow system - Line extension Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDB, JDC Dated: August 30, 2022 Received: September 16, 2022
Dear Kenneth Newman:
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/cfpm/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.
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
1
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 (OS) 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 provisions (Sections (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,
Victoria Lilling, M.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) K222807
Device Name TEMA Elbow system - Line extension
Indications for Use (Describe)
TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:
-
- Elbow joint destruction which significantly compromises the activities of daily living
-
- Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
-
- Rheumatoid arthritis or degenerative arthritis with incapacitating pain
-
- Revision where other devices or treatments have failed.
-
- Correction of severe functional deformity.
-
- Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
-
- Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of disengagement between ulnar and humeral components, when intraoperative manual testing is performed.
| 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: October 21, 2022
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Kenneth Newman Regulatory Affairs Associate kenneth.newman@limacorporate.comLima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Cell Phone: 682.597.3381 Office Phone: 817.385.0777 FAX: 817.385.0377
| Product | Product
Code | Regulation and Classification Name |
|---------------------------------------|-----------------|-----------------------------------------------------------------------------------|
| TEMA Elbow System
– Line extension | JDC | 21 CFR 888.3150 Elbow joint metal/polymer
constrained cemented prosthesis |
| | JDB | 21 CFR 888.3160 Elbow joint metal/polymer
semi-constrained cemented prosthesis |
Description:
TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.
TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.
The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.
The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.
TEMA Elbow system - Line extension introduces two new sizes of Ulnar stems to the ulnar stem range already cleared; moreover, a design change is introduced for the axle component, ulnar body component and for the humeral body compared to the original cleared version.
4
Indication for Use:
TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:
-
- Elbow joint destruction which significantly compromises the activities of daily living
-
- Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
-
- Rheumatoid arthritis or degenerative arthritis with incapacitating pain
-
- Revision where other devices or treatments have failed.
-
- Correction of severe functional deformity.
- Treatment of acute or chronic fractures with distal humerus epicondyle 6. involvement.
-
- Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.
Predicate Devices:
| Company | Device name | Cleared via |
|---|---|---|
| LIMACORPORATE | TEMA Elbow system | K181362 |
Summarv of technology comparison:
TEMA Elbow system - line extension and TEMA Elbow system (predicate device) have extensive and significant similarities in terms of intended use, indications, technological characteristics, materials, and principles of operation. The differences between these two systems are related to a design improvement of axle, humeral body and ulnar body components aimed to improve the overall mechanical performance and laxity of the system plus the addition of two new sizes of Ulnar stems.
A comparison of technological characteristics and performance testing demonstrate that the TEMA Elbow system-line extension is substantially equivalent to the predicate devices.
Non-clinical testing
Mechanical evaluations (both bench tests and rationales) demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:
- Range of motion:
- Stability, fatigue and fretting-corrosion evaluation post-fatigue of modular ● connections;
- Wear evaluation. ●
5
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the TEMA Elbow system – Line extension components to the predicate device.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the TEMA Elbow system - Line extension components are substantially equivalent to the predicate device components identified in this premarket notification.