(64 days)
The Sustain Spacer 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 Sustain Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The Sustain Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Sustain Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.
The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295.
The Sustain Spacer is a vertebral body replacement device. The provided text indicates that its acceptance criteria and performance were established through mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | In accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 | "Mechanical testing... was presented." (Details of specific results are not provided in the summary, but the general statement confirms testing against the guidance.) |
| Material Compatibility | Made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295 | "The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295." |
2. Sample size used for the test set and the data provenance:
The provided text details mechanical testing and material specifications. This type of testing typically involves physical samples of the device components. The document does not specify the sample size used for the mechanical tests, nor does it explicitly mention data provenance in terms of country of origin or whether the data was retrospective or prospective. Such details are usually found in the full test report, not the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For mechanical testing, "ground truth" is typically established by engineering standards and validated testing protocols, not by expert medical review. Therefore, this section is not applicable in the context of the provided information, which focuses on mechanical and material properties. The standard mentioned, "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", sets the technical benchmark.
4. Adjudication method for the test set:
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes. For mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and their alignment with established engineering standards. Therefore, this section is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The provided information focuses on the mechanical and material equivalence of the Sustain Spacer to predicate devices through engineering testing, not on clinical effectiveness with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is typically relevant for AI/software devices. Since the Sustain Spacer is a physical medical implant, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable.
7. The type of ground truth used:
The ground truth used for demonstrating the device's performance is based on engineering standards and specifications. Specifically, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000, and ASTM material standards (F67, F136, F1295) serve as the benchmarks against which the device's mechanical and material properties are measured.
8. The sample size for the training set:
The concept of a "training set" is relevant for machine learning algorithms. Since the data described pertains to mechanical and material testing of a physical implant, a "training set" in the machine learning sense is not applicable.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" is not applicable here. The "ground truth" for the device's performance was established by recognized industry standards and guidance documents for spinal implants, which dictate the required mechanical properties and material composition.
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III. 510(K) SUMMARY
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SUBMITTED BY:
JUN 2 7 2003
Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 994-3164 Contact: Daniel S. Paul
DEVICE NAME:
Sustain Spacer
CLASSIFICATION:
Per CFR 21, §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. Product code is MQP. The Panel code is 87.
PREDICATE DEVICES:
Synthes SynMesh System: K003275 SE date: April 23, 2001 And Synthes Vertebral Spacer Ti: K020152 SE date: April 16, 2002 And Synthes Vertebral Spacer Ti (Narrow and Curved): K024364 SE Date: March 17, 2003
DEVICE DESCRIPTION:
The Sustain Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectorny or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.
The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295.
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INTENDED USE:
K031302
Page 2 of 2
The Sustain Spacer 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 Sustain Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The Sustain Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
PERFORMANCE DATA:
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 was presented.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Sustain Spacer implants are similar to the predicate Synthes SvnMesh vertebral body replacement device(s). (K003275) and Synthes Vertebral Spacer Ti vertebral body replacement device(s) (K020125 and K024364) with respect to technical characteristics and performance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of three curved lines.
Public Health Service
JUN 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel S. Paul Direactor, Quality Assurance and Regulatory Affairs Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460
K031302 Trade Name: Sustain Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 23 and May 13, 2003 Received: April 24 and May 15, 2003
Dear Mr. Paul:
Re:
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 - Mr. Daniel S. Paul
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,
b. Mark A. Millessen
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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Indications for Use Statement
K031302 510(k) Number:
Device Name: Sustain Spacer
Indications:
The Sustain Spacer 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 Sustain Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The Sustain Spacer is designed to provide anterior spinal.column support even in the absence of fusion for a prolonged period.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
03/302
Mark N. Milliken
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number_
§ 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.