(130 days)
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Not Found
No
The description focuses on the materials and mechanical design of a shoulder implant, with no mention of AI/ML for diagnosis, planning, or any other function.
Yes
The device is a glenoid component for total shoulder arthroplasty, indicated for treating various joint diseases and deformities, which are conditions that impair normal body function. Its purpose is to restore joint function, aligning with the definition of a therapeutic device.
No
The document describes a medical implant (a glenoid component for shoulder arthroplasty) used for treatment/replacement purposes, not for diagnosing conditions. Its primary function is to replace or correct anatomical structures.
No
The device description clearly details physical components made of metal and polyethylene, indicating it is a hardware medical 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 treating various shoulder joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a shoulder implant (metal baseplate and polyethylene insert). This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Gemini Revision Glenoid is indicated for un-cemented use for the following indications:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- . rheumatoid arthritis;
- correction of functional deformity; .
- other difficult management problems where arthrodesis or resectional arthroplasty are not . acceptable (e.g. revision of a failed primary component);
- . cuff tear arthropathy.
Uncemented fixation may be supplemented by optional screw fixation.
Product codes (comma separated list FDA assigned to the subject device)
KWS, MBF
Device Description
The Encore Metal-Backed Revision Clenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene insert.
Metal Baseplate
The metal baseplate component, manufactured from Ti-6Al-4V per ASTM F136, is porous coated with commercially pure titanium (per ASTM F67 grade 2). It has an integrated central screw that provides initial fixation of the glenoid component as well as compression between the baseplate and the glenoid surface. HA porous coating on the surface of the medial side of the baseplate promotes biological fixation. No enhanced claims regarding the calcium phosphate coating will be made for this device. Additional fixation of the baseplate is achieved using four peripheral screws that can lock to the baseplate or have varying angles. All screws are manufactured from Ti-6Al-4V per ASTM F136.
Polyethylene Insert
The polyethylene inscrt component, molded from Ultra High Molecular Weight Polyethylene (per ASTM F648), snaps into the baseplate and provides a smooth bearing surface with the humeral head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
0
Image /page/0/Picture/1 description: The image shows a series of handwritten alphanumeric characters. The characters appear to be "K081448", written in a cursive style. The handwriting is somewhat uneven, with variations in stroke thickness and letter formation.
Summary of Safety and Effectiveness
Date: September 3, 2008
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager. Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany hutto@encoremed.com
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| Encore Shoulder System | KWS | Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis per 21 CFR 888 3660 |
Description:
The Encore Metal-Backed Revision Clenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene insert.
Metal Baseplate
The metal baseplate component, manufactured from Ti-6Al-4V per ASTM F136, is porous coated with commercially pure titanium (per ASTM F67 grade 2). It has an integrated central screw that provides initial fixation of the glenoid component as well as compression between the baseplate and the glenoid surface. HA porous coating on the surface of the medial side of the baseplate promotes biological fixation. No enhanced claims regarding the calcium phosphate coating will be made for this device. Additional fixation of the baseplate is achieved using four peripheral screws that can lock to the baseplate or have varying angles. All screws are manufactured from Ti-6Al-4V per ASTM F136.
Polyethylene Insert
The polyethylene inscrt component, molded from Ultra High Molecular Weight Polyethylene (per ASTM F648), snaps into the baseplate and provides a smooth bearing surface with the humeral head.
The Gemini Revision Glenoid is indicated for un-cemented use for the following indications:
- . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- . rheumatoid arthritis:
- correction of functional deformity; .
- other difficult management problems where arthrodesis or resectional arthroplasty are not . acceptable (e.g. revision of a failed primary component);
- . cuff tear arthropathy.
Uncemented fixation may be supplemented by ontional screw fixation.
1
Intended Use: Encore Medical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use. While shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Predicate Devices:
Bio-Modular Shoulder System - Biomet Orthopedics, Inc.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, sterilization, and indications for use.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided.
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 a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
SEP 3 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K081448 Trade/Device Name: Encore Shoulder system - Mctal Backed Revision Glenoid Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/poly-mer/metal nonconstrained or semiconstrained porous-coated uncemented prosthesis. Regulatory Class: Class II Product Code: MBF Dated: September 03, 2008 Received: Scptember 04, 2008
Dear Ms. Hutto:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Teffany Hutto
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, plcase note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K081448 510(k) Number (if known):
Device Name: Shoulder System
Indications for Use:
Encore Shoulder System - Metal-Backed Revision Glenoid Indications for Use
The Gemini Revision Glenoid is indicated for un-cemented use for the following indications:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- . rheumatoid arthritis;
- correction of functional deformity; .
- other difficult management problems where arthrodesis or resectional arthroplasty are not . acceptable (e.g. revision of a failed primary component);
- . cuff tear arthropathy.
Uncemented fixation may be supplemented by optional screw fixation.
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number `kod/448