(141 days)
No
The document describes a physical implant device (glenoid component) and its intended use in shoulder arthroplasty. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies refer to material interfaces and articulating surface geometry, not computational analysis.
Yes
The device is a prosthetic replacement indicated for the treatment of various medical conditions, aiming to alleviate pain and disability, which falls under the definition of a therapeutic device.
No
The device is described as a prosthetic replacement and implantable component (glenoid component) for joint replacement surgery, not a tool for diagnosis.
No
The device description clearly describes a physical implant (monoblock glenoid component) made of Trabecular Metal and polyethylene, intended for surgical implantation. It is not a software-only device.
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 replacing a joint (glenohumeral joint) to treat various musculoskeletal conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a physical implant component (glenoid component) made of specific materials and designed to articulate with other implant components. This is consistent with a surgical device, not a diagnostic kit or instrument.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be cemented in place in the USA.
Product codes
KWS, KWT
Device Description
This new implant device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. The resulting implant, the Trabecular Metal Glenoid, is designed to interface & articulate with Zimmer B/F humeral components. The subject device is available in one thickness option of 5 mm, and the same outer profile options as the B/F all-polyethylene glenoid. The range of outer profile options include 40, 46, and 52 mm round shapes, and 40 by 46 mm, 46 by 52 mm, and 52 by 56 mm oval shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral 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
Performance data for the UHMPWE and Hedrocel Trabecular Metal interface can be found in Implex MAF #920, and for the articulating surface geometry in K982981.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation 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, 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “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 OF SAFETY AND EFFECTIVENESS
The Trabecular Metal Glenoid
ow (B/F) The Complete Shoulder Solution Blaliani/Flatow
| Submitter Name And Address: | Implex Corp.
80 Commerce Drive
Allendale, New Jersey 07401-1600 |
|-----------------------------|-----------------------------------------------------------------------|
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (201) 818-1800 X 519 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | November 19, 2002 |
DEC 1 0 2002
| Device Trade Name: | The Trabecular Metal Glenoid, the B/F Complete Shoulder Solution |
|---|---|
| Device Common Name: | Glenoid Component |
| Classification Number and Name: | 21 CFR 888.3660 & 888.3650; Prosthesis, shoulder, semi & non- |
| constrained, metal/polymer cemented. |
Substantial The term "substantial equivalence" as used in this 510(k) notification is Equivalence: limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
Device This new implant device is a monoblock glenoid component comprised Description: of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. The resulting implant, the Trabecular Metal Glenoid, is designed to interface & articulate with Zimmer B/F humeral components. The subject device is available in one thickness option of 5 mm, and the same outer profile options as the B/F all-polyethylene glenoid. The range of outer profile options include 40, 46, and 52 mm round shapes, and 40 by 46 mm, 46 by 52 mm, and 52 by 56 mm oval shapes.
1
TM Glenoid, B/F Should
510(k) Premarket Notification
510(k) Summary (Continued)
Indications for Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, Use: rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be cemented in place in the USA.
The subject device possesses the same articulation geometry, Device minimum polyethylene thickness and outer profile options as the Technological predicate B/F all-poly glenoid components. The Trabecular Metal, Characteristics & direct compression molded polyethylene and monoblock design is Comparison to similar to numerous cleared Implex devices. Predicate Device:
Performance data for the UHMPWE and Hedrocel Trabecular Metal Performance interface can be found in Implex MAF #920, and for the articulating Data: surface geometry in K982981.
The Trabecular Metal Glenoid is substantially equivalent to the identified Conclusion: predicate devices identified in this premarket notification based on the similarity in technological characteristics and indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert A. Poggie, PhD Director of Applied Research Implex Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K022377
Trade/Device Name: The Trabecular Metal Glenoid – Bigliani/Flatow®, The Complete Shoulder Solution
Regulation Number: 21 CFR §888.3660 and §888.3650
Regulation Name: Shoulder Joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint metal/polymer non-constrained cemented prosthesis
Regulatory Class: Class II Product Code: KWS and KWT Dated: October 25, 2002 Received: October 28, 2002
Dear Dr. Poggie;
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.
3
Page 2 - Dr. Robert A. Poggie
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Implex Corp
TM Glenoid, B/F Shoulder Special 510(k) Premarket Notification
510(k) Number (if known) :
Device Name:
The Trabecular Metal Glenoid - The B/F Complete Shoulder Solution
Indications For Use:
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be cemented in place in the USA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODF)
Division Sign-Off
Division of General, Restorative
and Neurological Devices
| Prescription Use (Per 21 CFR 801.109) | OR... | 510(k) Number |
|---|---|---|
| Over-The-Counter Use |
K022377(Optional Format 1-2-96)