(139 days)
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 fully or partially cemented in place in the USA.
The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. This device was cleared in K022377. The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same outer profile options as the B/F allpolyethylene glenoid.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Trabecular Metal Glenoid:
This document is a 510(k) Summary for a medical device called the Trabecular Metal Glenoid. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence for regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (Specific Data) |
|---|---|
| Equivalence in component stability for partial cementing techniques compared to predicate. | Displacement data indicated equivalence for the partial cementing techniques for the TM Glenoid and the predicate all-poly glenoid for cyclic loading through 3600 cycles. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states "Component stability testing was performed per ASTM F 2080-00 for the subject and predicate devices and cementing techniques."
- Sample Size: The exact number of samples (e.g., individual glenoid components tested) is not explicitly stated. However, it implies multiple samples were tested to generate "displacement data."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It describes laboratory testing of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This study is a mechanical performance test (component stability testing) against an ASTM standard, not a clinical study involving human assessment of ground truth. Therefore, there were no "experts" establishing ground truth in the traditional sense of a clinical trial. The "ground truth" here is the performance against the defined parameters of the ASTM F 2080-00 standard.
4. Adjudication Method for the Test Set:
- None. As this is a mechanical performance test, there is no need for an adjudication method for a test set in the way one would adjudicate clinical data. The results are based on objective measurements of displacement during cyclic loading.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No. This document describes a mechanical performance study, not a clinical MRMC study. There is no assessment of human reader performance, with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, in spirit. The performance described is for the device itself ("algorithm only" in the context of mechanical testing), not involving human interaction as part of the primary performance evaluation. The "displacement data" is a direct measurement of the device's physical properties under specific loading conditions.
7. The Type of Ground Truth Used:
- The ground truth is based on mechanical performance specifications/standards, specifically ASTM F 2080-00 for component stability. The "ground truth" is that the device should demonstrate similar or equivalent stability performance to the predicate device under the defined testing parameters.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data. The "training" for such a device is its design, manufacturing processes, and adherence to established engineering principles.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no "training set" for a physical device in the context described in the prompt. The "ground truth" for the device's design and manufacturing is established through engineering specifications, material science, and adherence to quality control standards.
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Supplement to Special 510(k)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The Trabecular Metal Glenoid 8 (B/F) The Complete Shoulder Solution Bigliani/Flatow
| Submitter NameAnd Address: | Implex Corp.80 Commerce DriveAllendale, New Jersey 07401-1600 |
|---|---|
| Contact Person: | Robert Poggie, Ph.D. |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | August 12, 2003 |
| Device Trade Name: | The Trabecular Metal Glenoid, the B/F Complete Shoulder Solution |
| Device Common Name: | Glenoid Component |
| Classification Numberand 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 The device is a monoblock glenoid component comprised of a Description: Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. This device was cleared in K022377. The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same outer profile options as the B/F allpolyethylene glenoid.
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Implex Corp
Supplement to Special 510(k) K03
510(k) Summary (Continued)
- 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 fully or partially cemented in place in the USA.
- Device The subject device is identical to the predicate Trabecular Metal Technological Glenoid, and possesses the same articulation geometry, minimum polyethylene thickness and outer profile options as the predicate B/F all-Characteristics & poly glenoid components. The Trabecular Metal, direct compression Comparison to molded polyethylene and monoblock design is similar to numerous Predicate Device: cleared Implex devices. This 510(k) clearance provides for the addition of a partial cementing technique (to the base) to the already cleared, fully cemented technique.
- Performance Component stability testing was performed per ASTM F 2080-00 for the subject and predicate devices and cementing techniques. Data: The displacement data indicated equivalence for the partial cementing techniques for the TM Glenoid and the predicate all-poly glenoid for cyclic loading through 3600 cycles.
- Conclusion: The Trabecular Metal Glenoid is substantially equivalent to the identified predicate devices identified in this premarket notification based on the similarity in technological characteristics, indications for use, testing per ASTM F 2080-00, and subsequent analysis of the data and tested components and foam materials.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
SEP 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert A. Poggie, Ph.D. Director. Applied Research Implex Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600
Received: August 26, 2003
Re: K031449
Trade/Device Name: Trabecular Metal Glenoid for the Bigliani/Flatow, The Complete Shoulder Solution Regulation Number: 21 CFR 888.3660 and 888.3650 Regulation Names: Shoulder joint metal/polymer semi-constrained cemented prosthesis, and Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Codes: KWS and KWT Dated: August 12, 2003
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.
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
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Page 2 - Robert A. Poggie, Ph.D.
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), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
L. Merle A. Wilkerson
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
Enclosure
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510 (k) Number (if known) :
K031449 Page 1 of 1
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 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 fully or partially cemented in place in the USA.
Mark A. Milham
Division Sign-Division of General. Restorative and Neurological Dev
510(k) Number K031449
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescriptio n Use (Per 21 CFR 801.109) OR . . .
Over - The -Counter Use
(Optional Format 1-2-96)
§ 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.”