(271 days)
No
The document describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat medical conditions like osteoarthritis, rheumatoid arthritis, and fractures, and it is an implantable shoulder prosthetic component, all of which fall under the definition of a therapeutic device.
No
The device is a Modular Hybrid Glenoid, which is an implantable medical device used in shoulder arthroplasty for conditions like osteoarthritis and rheumatoid arthritis. Its purpose is to correct functional deformities and replace damaged bone, not to diagnose a disease or condition.
No
The device description clearly outlines physical components made of polyethylene and titanium, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "Modular Hybrid Glenoid," which is a component of a shoulder replacement system. Its intended use is for surgical implantation to treat various shoulder joint conditions.
- Lack of Diagnostic Function: The device itself does not perform any tests on biological samples. It is a physical implant designed to replace or augment a damaged anatomical structure.
The information provided describes a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate
The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Product codes
KWS, KWS, KWT
Device Description
The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.
The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.
The porous titanium peg provides the surgeon with an option for potential tissue ingrowth fixation. The peg is circular in design and tiered. Similar to the polvethylene peg, the porous titanium peg has a central titanium rod to provide a threaded connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. A full characterization of the porous titanium construct has been provided.
Clinical Testing: None provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030710, K992119, K043061, K031449, K022377, K052472, K981487
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in large, bold, block letters at the top of the image. Below that, in a smaller font, is the text "ORTHOPEDICS, INC."
510(k) Summary
DEC 1 1 2006
December 8, 2006 Preparation Date:
Applicant/Sponsor:
Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0588
Contact Person:
Patricia Sandborn Beres Senior Regulatory Specialist Phone: (574) 267-6639 FAX: (574) 372-1683
Proprietary Name: Modular Hybrid Gleniod
Common Name: Total shoulder replacement components
Classification Name:
-
- Prosthesis, Shoulder, Non-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3650)
-
- Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Comented (21 CFR Section 888.3660)
Legally Marketed Device to which Substantial Equivalence is claimed:
- Bio-Modular® Shoulder System (Biomet) .
- The Trabecular Metal™ Glenoid (Zimmer) .
K030710, K992119 K043061. K031449, K022377 K052472, K981487
- DePuy Global™ Shoulder Glenoid (DePuy) .
Device Description: The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.
The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.
The porous titanium peg provides the surgeon with an option for potential tissue ingrowth fixation. The peg is circular in design and tiered. Similar to the polvethylene peg, the porous titanium peg has a central titanium rod to provide a threaded connection.
| MAILING ADDRESS | P.O. Box 587
Warsaw, IN 46581-0587 |
|------------------|---------------------------------------|
| | D - 1 |
| SHIPPING ADDRESS | 56 E. Bell Drive
Warsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| E-MAIL | biomet@biomet.com |
1
Indications for Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Correction of functional deformity
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
-
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate
The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Summary of Technologies: The materials, surface finishes and processing of the Modular Hybrid Glenoid are similar to the predicate device.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. A full characterization of the porous titanium construct has been provided.
Clinical Testing: None provided.
All trademarks of property of Biomet, Inc. except for the following: Global is a trademark of DePuv. Inc. Hedrocel and Trebecular Metal are trademarks of Zimmer Trabecular Metal Technology, Inc.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
DEC 1 1 2006
Re: K060694
Trade/Device Name: Modular Hybrid Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer, semi-constrained, cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWS, KWT Dated: November 20, 2006 Received: November 21, 2006
Dear Ms. Beres:
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.
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. Patricia Sandborn Beres
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara MnehuD
fo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Modular Hybrid Gleniod
Indications For Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Correction of functional deformity
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
-
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate
The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buellind Somon
606694
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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