(28 days)
Not Found
No
The summary describes a new glenoid component for a shoulder replacement system, focusing on material and design changes. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device description clearly states it is a keeled and pegged glenoid for a shoulder system, designed for joint replacement in cases of joint disease, fracture, or failed surgical attempts. This description indicates it is a prosthetic implant, not a therapeutic device.
No
Explanation: The provided text describes a joint replacement system used for surgical intervention, not for diagnosing medical conditions. Its intended use is to replace affected joints due to various degenerative diseases or fractures.
No
The device description explicitly states it is a "new keeled and pegged glenoid for the Turon Shoulder System manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E," indicating it is a physical implant made of materials like UHMWPE. The performance studies also describe testing on physical components (cyclic displacement, pull-out, impact resistance, etc.).
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 joint replacement to treat conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a keeled and pegged glenoid, which is a component of a shoulder joint replacement system. This is a physical implant, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical implant used in the body for treatment.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- . correction of functional deformity:
- . humeral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
Product codes (comma separated list FDA assigned to the subject device)
KWS, PAO
Device Description
The purpose of this application is to include a new keeled and pegged glenoid for the Turon Shoulder System manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral head and/or glenoid
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: Testing included: cyclic displacement test, glenoid pull-out test, impact resistance, small punch testing, tensile testing, oxidation testing, biocompatibility, and cytotoxicity.
Clinical Testing: None provided.
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
§ 888.3660 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
510(k) Summary
Date: December 19, 2012
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Michaela Norris Regulatory Affairs Associate Phone: (512) 834-6291 Fax: (512) 834-6313 Email: michaela.norris@djoglobal.com
| Product | Classification | Product Code |
|---|---|---|
| Turon e+ Glenoid | Class II | KWS - Shoulder joint metal/polymer |
| semiconstrained cemented prosthesis per 21 | ||
| CFR 888.3660 | ||
| PAO - Shoulder joint metal/polymer | ||
| semiconstrained cemented prosthesis per 21 | ||
| CFR 888.3660 |
Description: The purpose of this application is to include a new keeled and pegged glenoid for the Turon Shoulder System manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- . correction of functional deformity:
- . humeral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
Predicate Devices:
DJO Surgical Encore Shoulder System - K080402 DJO Surgical Highly Crossed-Linked VE Polyethylene Material UHMWPE Tibial Insert - K091956
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use.
Non-Clinical Testing: Testing included: cyclic displacement test, glenoid pull-out test, impact resistance, small punch testing, tensile testing, oxidation testing, biocompatibility, and cytotoxicity.
Clinical Testing: None provided.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 23, 2013
Encore Medical, L.P. % Ms. Michaela Norris Regulatory Affairs Associate 9800 Metric Boulevard Austin, Texas 78758
Re: K123982
Trade/Device Name: Turon e+ Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semiconstrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, PAO Dated: December 19, 2012
Received: December 26, 2012
Dear Ms. Norris:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Ms. Michaela Norris
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). regulations 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.htmfor 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K123982 510(k) Number (if known): J
Device Name: Turon e+ Glenoid
Indications for Use:
Turon e+ Glenoid Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- correction of functional deformity; .
- humeral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi, PhD Division of Orthopedic Devices