(76 days)
The Vertebral Spacer Ti 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 Vertebral Spacer Ti System is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Vertebral Spacer Ti can be packed with bone.
The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of: vertebral body replacement devices comprised of a variety of fixed heights and cross-sections. supplemental fixation currently cleared for use in treating patients for tumor, trauma or fractures of the vertebral body and manual surgical instrumentation used to prepare the anatomy and implant the Vertebral Spacer Ti. There are no unique surgical instruments required for implantation of the submitted device system.
This document describes the Synthes Vertebral Spacer Ti, a titanium vertebral body replacement device. The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as demonstrating this substantial equivalence through comparison and testing against a recognized standard or predicate.
Here's the breakdown of the information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission and not a new AI device or diagnostic, the "acceptance criteria" are based on demonstrating mechanical soundness and substantial equivalence to an already cleared predicate device. The performance is assessed against recognized standards for spinal implants.
| Acceptance Criteria Category | Specific Acceptance Criteria (based on industry guidance) | Reported Device Performance (as summarized in the document) |
|---|---|---|
| Material Composition | Commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295). | All components are manufactured from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295). |
| Mechanical Performance | Meets mechanical testing requirements outlined in "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000. | Mechanical testing in accordance with the specified guidance document was presented. |
| Substantial Equivalence | Demonstrably similar to the predicate device (Synthes Vertebral Spacer, Ti: K020152) in technical characteristics and performance. | The Vertebral Spacer Ti implants are similar to the predicate Synthes Vertebral Spacer Ti body replacement device(s) (K020152) with respect to technical characteristics and performance. |
| Intended Use | Consistent with the predicate device and the supplemental fixation systems cleared for use. | 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), to be used with Synthes supplemental internal fixation systems already cleared for use. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable to this 510(k) premarket notification for a mechanical spinal implant. There is no "test set" in the context of diagnostic accuracy for AI or clinical images. The "testing" primarily involved mechanical bench testing of the device's physical properties. The data provenance would be laboratory testing rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. "Ground truth" in the context of expert consensus on patient data or pathology is not relevant for the regulatory clearance of a mechanical spinal implant through a 510(k) pathway. The "ground truth" for material and mechanical performance relies on established scientific and engineering standards.
4. Adjudication Method for the Test Set
This is not applicable as there is no "test set" in the diagnostic or clinical sense requiring expert adjudication.
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
This is not applicable. This device is a mechanical implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a mechanical implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this mechanical spinal implant, the "ground truth" for its performance relies on:
- Material specifications: Conformance to industry standards like ASTM F67 and F1295.
- Mechanical engineering principles: Adherence to established biomechanical testing protocols outlined in FDA guidance documents (e.g., "Guidance for Spinal System 510(k)s").
- Predicate device performance: The previously cleared Synthes Vertebral Spacer Ti (K020152) serves as the benchmark for established safety and effectiveness.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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Ko 2456 Premarket Notification - Vertebral Spacer Ti
Summary of Safety and Effectiveness Information 3.0
| SPONSOR: | MAR 1 7 2003Synthes Spine Company, L. P.1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Jonathan Gilbert |
|---|---|
| DEVICE NAME: | Synthes Vertebral Spacer Ti |
| CLASSIFICATION: | Per CFR 21, §888.3060: Implant, fixation, spinal intervertebralbody fixation orthosis devices. Class II.Product code is MQP. The Panel code is 87. |
| PREDICATE DEVICE: | Vertebral body replacement device:Synthes Vertebral Spacer, Ti: K020152SE date: April 16, 2002. |
| DEVICEDESCRIPTION: | The Vertebral Spacer Ti is a titanium vertebral bodyreplacement device used in conjunction with supplementalinternal fixation to provide structural stability in skeletallymature individuals following corpectomy or vertebrectomy andconsists of:vertebral body replacement devices comprised of a varietyof fixed heights and cross-sections.supplemental fixation currently cleared for use in treatingpatients for tumor, trauma or fractures of the vertebral bodyandmanual surgical instrumentation used to prepare theanatomy and implant the Vertebral Spacer Ti.There are no unique surgical instruments required forimplantation of the submitted device system. |
| INTENDED USE: | The Vertebral Spacer Ti is a vertebral body replacement deviceintended for use in the thoracolumbar spine (T1-L5) to replacea collapsed, damaged, or unstable vertebral body due to tumoror trauma (i.e., fracture). The Vertebral Spacer Ti System isintended to be used with Synthes supplemental internal fixationsystems, e.g., ATLP, VentroFix, USS and Small Stature USS.The interior of the spacer component of the Vertebral Spacer Tican be packed with bone.The Vertebral Spacer Ti is designed to provide anterior spinalcolumn support even in the absence of fusion for a prolongedperiod. |
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All components of the Vertebral Spacer Ti are manufactured MATERIAL: from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295).
Mechanical testing in accordance with the "Guidance for PERFORMANCE Industry and FDA Staff, Guidance for Spinal System 510(k)s", DATA: September 27, 2000 was presented.
The Vertebral Spacer Ti implants are similar to the predicate BASIS OF Synthes Vertebral Spacer Ti body replacement device(s), SUBSTANTIAL (K020152) with respect to technical characteristics and EQUIVALENCE: performance. The supplemental fixation devices intended for use with the Vertebral Spacer Ti implants are currently cleared for use in patients with either tumor, trauma or fractures.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2003
Mr. Jonathan Gilbert RA Project Manager Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
Re: K024364
Trade/Device Name: Synthes Vertebral Spacer Ti Regulatory Number: 21, CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 30, 2002 Received: December 31, 2002
Dear Mr. Gilbert:
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 - Mr. Jonathan Gilbert
forth in the quality systems (OS) 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. 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 M. Millenn
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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2.0 Indications for Use Statement
510(k) Number (if known):
Synthes Vertebral Spacer Ti Device Name:
Indications:
The Vertebral Spacer Ti 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 Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the 7i Spacer System can be packed with bone.
The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
for Mark N. Milliken
Division Sign-Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
024364 510(k) Number_
Synthes Spine Company, L. P. Vertebral Spacer Ti 510(k)
§ 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.