(120 days)
No
The document describes a mechanical elbow prosthesis and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is intended to relieve severe pain or significant disability, restore the elbow joint to its best working condition, and reduce or eliminate pain, which are therapeutic goals.
No
The device is an Elbow Prosthesis intended for total elbow arthroplasty, which is a treatment for severe pain or disability, not a tool for diagnosing conditions.
No
The device description clearly states it is a 3-part system consisting of physical components (humeral, ulnar, and radial components) intended for surgical implantation. It also mentions mechanical bench testing and cadaver evaluations, which are typical for physical implants, not software-only devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "total elbow arthroplasty" and is a "prosthetic replacement." This describes a surgical implant used to replace a joint.
- Device Description: The description details a "3-part system consisting of a humeral, an ulnar and a radial component" which are physical implants for 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 an in vivo (inside the body) implant.
N/A
Intended Use / Indications for Use
The Tornier Inc. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.
Product codes
JDB, JDC
Device Description
Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. They are also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Inc. Latitude Elbow Prosthesis is intended to accomplish these goals. The Tornier Inc. Latitude Elbow Prosthesis is intended for use as a cemented total elbow.
The Tornier Inc. Latitude Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component.The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus. The prosthesis is a non constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a constrained prosthesis.
The present device submission corresponds to several changes made to the device cleared in the latest 510k K070787.
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)
The modifications made to the proposed Tornier Inc. Latitude Elbow Prosthesis were verified and validated by performing Cadaver evaluations; CAD evaluations; Mechanical bench testing; as well as Sterilization and Packaging validation. The results of those evaluations allow us to conclude that the proposed Tornier Inc. Latitude Elbow Prosthesis described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K000003, K011567, K031218, K050848, K070787
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION 5
510(k) SUMMARY
Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - Tornier Inc. Latitude Elbow Prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
Trade name: Latitude Elbow Prosthesis Common name: Elbow Prosthesis Elbow joint metal/polymer semi-constrained cemented prosthesis Classification name: Elbow joint metal/polymer constrained cemented prosthesis 888.3160 and 888.3150 Classification number:
2) Submitter
Tornier Inc. 3601 West 76th Street Suite 200 Edina, MN 55435 Registration Number: 9100540
3) Company contact
Brahim Hadri Sr. Regulatory affairs Specialist 100 Cummings Center, Suite 444C, Beverly, MA 01915, U.S.A Phone: 1 978 232-9997 ext: 617 1 978-232-9998 Fax:
-
- Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | JDB and JDC |
5) Equivalent / Predicate device
Tornier Latitude Elbow Prosthesis, K000003, K011567, K031218, K050848 and K070787
1
6) Device description
Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. They are also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Inc. Latitude Elbow Prosthesis is intended to accomplish these goals. The Tornier Inc. Latitude Elbow Prosthesis is intended for use as a cemented total elbow.
The Tornier Inc. Latitude Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component.The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus. The prosthesis is a non constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a constrained prosthesis.
The present device submission corresponds to several changes made to the device cleared in the latest 510k K070787.
7) Materials
The humeral stem is available in CoCr alloy. The humeral spool is available in CoCr alloy with a PEEK-OPTIMA polymer insert. The humeral screw is available in stainless steel. The radial components are made of CoCr alloy and UHMWPE. The ulnar assembly has a stem component made of CoCr alloy and a bushing made of UHMWPE.
8) Indications
The Tornier Inc. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthitis and rheumatoid arthritis; correction of functional, deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.
9) Substantial Equivalence
The modifications made to the proposed Tornier Inc. Latitude Elbow Prosthesis were verified and validated by performing Cadaver evaluations; CAD evaluations; Mechanical bench testing; as well as Sterilization and Packaging validation. The results of those evaluations allow us to conclude that the proposed Tornier Inc. Latitude Elbow Prosthesis described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. To the right of the text is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 2 9 2010
Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
Re: K100562
Trade/Device Name: Latitude Elbow Prosthesis Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDB, JDC Dated: June 9, 2010 Received: June 11, 2010
Dear Mr. Hadri:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Brahim Hadri
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Olabare Brechmo
Mark N. Me Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KI005L.2
Indications for Use
510(k) Number (if known):
Device Name: Latitude Elbow Prosthesis
Indications For Use:
The Tornier Inc. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Nabare Breshn A.M.
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100562
510k Submission: Tornier Inc. Latitude Elbow Prosthesis
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