(27 days)
The Trabecular Metal Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
The Trabecular Metal Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.
The provided 510(k) summary for the Trabecular Metal Vertebral Body Replacement System focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and biocompatibility. It does not describe a study involving acceptance criteria for device performance based on diagnostic accuracy or clinical outcomes, as would be the case for AI/ML-enabled devices.
Therefore, many of the requested fields are not applicable to this submission.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a vertebral body replacement system, the "performance" here refers to mechanical and biocompatibility data, not diagnostic accuracy. The acceptance criteria would likely be specified in the cited standards and in comparison to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Expulsion | Performed as intended; equivalent to predicate devices. |
| Static Compression | Performed as intended; equivalent to predicate devices. |
| Dynamic Compression | Performed as intended; equivalent to predicate devices. |
| Static Torsion | Performed as intended; equivalent to predicate devices. |
| Dynamic Torsion | Performed as intended; equivalent to predicate devices. |
| Abrasion | Performed as intended; equivalent to predicate devices. |
| Biocompatibility: | Data provided to support material's use. |
Study that proves the device meets the acceptance criteria:
The submission states, "Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378 and current submission)." It also mentions, "Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicate devices."
The results demonstrated that the device "will perform as intended and is equivalent to the cited predicate devices." This implies that the acceptance criteria for mechanical properties (e.g., maximum deflection, load-bearing capacity, fatigue life as defined by the applicable standards) were met, and the biocompatibility data was deemed acceptable by the FDA.
2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This submission is for a physical implant, not an AI/ML-enabled device or a diagnostic tool that uses a "test set" of patient data. The "test set" would consist of physical devices tested in a lab. The number of devices tested for each mechanical performance criterion is not specified but would be conducted according to relevant ASTM or ISO standards for medical implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth in this context would be objective physical measurements of the device's mechanical properties or biological response in biocompatibility tests, not expert interpretation of images or clinical data.
4. Adjudication method for the test set
N/A. Adjudication methods are typically for resolving discrepancies in expert interpretations of data (e.g., in radiological reads). This is not relevant for mechanical testing or biocompatibility assessment of a physical implant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is a physical implant, not an AI-assisted diagnostic or clinical decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical performance, the "ground truth" would be the objective measurements of force, displacement, cycles, wear, etc., obtained through standardized laboratory testing procedures. For biocompatibility, the "ground truth" would be established through laboratory assays and animal studies according to ISO 10993 or equivalent standards.
8. The sample size for the training set
N/A. This is a physical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
N/A. This is a physical implant, not an AI/ML model.
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510(k) SUMMARY Trabecular Metal Vertebral Body Replacement System
| Trabecular Metal Vertebral Body Replacement System Page 1 of 2 | |
|---|---|
| Submitter NameAnd Address: | Zimmer Trabecular Metal Technology, Inc.80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818-1800 ext. 507 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | October 17, 2005 |
| Device Trade Name: | Trabecular Metal Vertebral Body Replacement System |
| Device Common Name: | Vertebral Body Replacement Device |
| Classification Numberand Name: | 21 CFR § 888.3060.Spinal Intervertebral Body Fixation Orthosis |
| DeviceDescription: | The Trabecular Metal Vertebral Body Replacement System isdesigned to be used as a replacement for a single diseased ordamaged vertebral body and the adjacent disc when spinal surgerythrough an anterior approach is indicated. |
The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.
The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.
- The Zimmer TMT Trabecular Metal Vertebral Body Replacement Indications for Use: System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
Device Technoloqical The device is unique in comparison to predicates for this Characteristics and indication with regard to its geometry. The material has been used in cited predicates for other applications. The Zimmer TMT Comparison to Predicate Device: Vertebral Body Replacement System is substantially equivalent to previously cleared components of this same system (K010378, K051196 and K051978).
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- Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378 and current submission). Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicate devices. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding:
- Expulsion, .
- Static compression, .
- Dynamic compression, .
- Static torsion, .
- Dynamic torsion, and
- . Abrasion.
Conclusion:
TMT Trabecular Metal The Zimmer Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification.
K052950 ge 2 of 2
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized representation of a human figure, composed of three curved lines. The figure is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
NOV 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology, Inc. 80 Commerce Drive Allendale, New Jersey 07401
Re: K052950
Trade/Device Name: Trabecular Metal Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 19, 2005 Received: October 20, 2005
Dear Ms. Halevi:
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.
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Page 2 - Ms. Marci Halevi
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and w yourse 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 If you dome office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jon Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson પ્રેમ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K05 2950
Device Name: The Zimmer TMT Trabecular Metal Vertebral Body Replacement System
Indications for Use:
The Trabecular Metal Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off Division of General, Rest rative. and Neurological Devices
510(k) Number_KOSQ950
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.