(163 days)
K142079, STALIF C®, STALIF C-TiTM
No
The summary describes a physical intervertebral body fusion cage and its materials, intended use, and performance studies (literature review and biomechanical testing). There is no mention of software, algorithms, image processing, AI, ML, or any data sets related to training or testing AI/ML models.
Yes
The device is an intervertebral body fusion cage intended for the treatment of cervical degenerative disc disease, which explicitly states its purpose is therapeutic for a medical condition.
No.
The provided text describes an intervertebral body fusion cage intended for surgical implantation to facilitate fusion, not for diagnosing a condition. Its use is related to treating an existing condition, not identifying one.
No
The device description clearly states it is a physical intervertebral body fusion cage made of PEEK or PEEK with a titanium coating, along with titanium screws and tantalum marker wires. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The STALIF C® and STALIF C-Ti™ devices are described as intervertebral body fusion cages intended for surgical implantation into the spine to facilitate bone fusion. They are physical implants used within the body, not tests performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or the use of reagents or laboratory equipment typically associated with IVDs.
Therefore, the STALIF C® and STALIF C-Ti™ devices are medical devices, specifically surgical implants, and do not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with titanium alloy screws (Ti6A14V, ASTM F136) and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F560). The STALIF C-Ti™ is identical to this design with a titanium plasma spray coating (CPT) per ASTM F1580) on the device endplates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2/C3 disc space to the C7/T1 disc space)
Indicated Patient Age Range
Skeletally mature patient
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A comprehensive, clinical literature review and PearlDiver reimbursement data have been provided to investigate the risks and benefits associated with the use of the STALIF C® devices in multilevel cervical procedures. Additionally, cadaveric biomechanical testing was conducted to support substantial equivalence.
Key results: STALIF C®, STALIF C-Ti™ and predicate STALIF C-Ti™ devices are identical in design, material, and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K142079, STALIF C®, STALIF C-TiTM
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K142264, Amedica Valeo® Cage
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines forming its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
July 31, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Centinel Spine, Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, District of Columbia 20005
Re: K150053
Trade/Device Name: STALIF C® and STALIF C-TiTM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: June 24, 2015 Received: June 24, 2015
Dear Mr. Eggleton:
This letter corrects our substantially equivalent letter of June 24, 2015.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
Page 2 - Mr. Justin Eggleton
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K150053 Page 1 of 2
510(k) Summary
| Device Trade Name: | STALIF C® and STALIF C-TiTM |
|---|---|
| Manufacturer: | Centinel Spine, Inc. |
| 900 Airport Road, Suite 3B | |
| West Chester, PA 19380 | |
| Contact: | Mr. John Parry |
| Development Manager | |
| Phone: (484) 887.8813 | |
| Prepared by: | Mr. Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | June 22, 2015 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | OVE |
| Primary Predicate: | K142079, STALIF C®, STALIF C-TiTM |
| Reference Device: | K142264, Amedica Valeo® Cage |
Indications For Use:
The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.
3
K150053 Page 1 of 2
510(k) Summary
| Device Trade Name: | STALIF C® and STALIF C-TiTM |
|---|---|
| Manufacturer: | Centinel Spine, Inc. |
| 900 Airport Road, Suite 3B | |
| West Chester, PA 19380 | |
| Contact: | Mr. John Parry |
| Development Manager | |
| Phone: (484) 887.8813 | |
| Prepared by: | Mr. Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | June 22, 2015 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | OVE |
| Primary Predicate: | K142079, STALIF C®, STALIF C-TiTM |
| Reference Device: | K142264, Amedica Valeo® Cage |
Indications For Use:
The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.
4
K150053 Page 2 of 2
Summary of Technological Characteristics:
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with titanium alloy screws (Ti6A14V, ASTM F136) and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F560). The STALIF C-Ti™ is identical to this design with a titanium plasma spray coating (CPT) per ASTM F1580) on the device endplates.
The purpose of the subject 510(k) was to expand the indications to allow for use in multilevel procedures (i.e., two contiguous levels).
Predicate Device:
The subject STALIF C and STALIF C-Ti™ intervertebral body fusion devices are substantially equivalent to predicate STALIF C-Ti™ (K142079) with respect to indications, design, function, and materials.
Substantial Equivalence:
STALIF C®, STALIF C-Ti™ and predicate STALIF C-Ti™ devices are identical in design, material, and performance. A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device (accounting for its integrated fixation features) at two cervical levels.
Performance Testing:
A comprehensive, clinical literature review and PearlDiver reimbursement data have been provided to investigate the risks and benefits associated with the use of the STALIF C® devices in multilevel cervical procedures. Additionally, cadaveric biomechanical testing was conducted to support substantial equivalence.
Conclusion:
The Centinel Spine STALIF C® and STALIF C-Ti™ have been modified to expand the indications to permit use in multilevel cervical procedures (i.e., one or two contiguous levels). The 510(k) demonstrates substantial equivalence to predicate devices.
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150053
Device Name STALIF C® and STALIF C-TiTM
Indications for Use (Describe)
The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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