(215 days)
The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIFTM TT system may be used with bone grafting material (autograft only).
The Surgicraft STALIF"M TT is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM TT is similar to that of the vertebral body endplate with a central cavity than can be packed with bone graft (autograft). The STALIFTMTT IBF System consists of varying sizes to include different widths, heights and hole positions to accommodate individual pathology and anatomical conditions.
This is a 510(k) premarket notification for the STALIF™ TT Intervertebral Body Fusion System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, many of the requested data points related to clinical study design and performance metrics are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This section is Not Applicable in the traditional sense of a clinical performance study with predefined acceptance criteria and measured device performance against those criteria. For medical devices pursuing 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device.
The study presented here asserts that the STALIF™ TT system meets the "acceptance criteria" of being substantially equivalent to its predicates based on:
| Acceptance Criteria (for Substantial Equivalence) | Reported Device "Performance" (Demonstration of Substantial Equivalence) |
|---|---|
| Similar Indications for Use (The device should be intended for the same or similar patient population and clinical use cases as the predicate.) | The STALIF™ TT system is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis. It's intended as a stand-alone system with bone screws and may be used with autograft. This aligns with the general indications for intervertebral body fusion devices, suggesting similarity to the predicate devices. |
| Similar Design Features (The device should have analogous structural and functional characteristics.) | The device is described as a radiolucent intervertebral body fusion device and unicortical cancellous bone screws. Its cross-section profile is similar to the vertebral body endplate with a central cavity for bone graft. It comes in varying sizes (widths, heights, hole positions). The submission asserts that engineering drawings confirm similar design features to predicates. |
| Similar Operational Principles (The device should function in a comparable manner to the predicate.) | As an intervertebral body fusion device, its operational principle is to provide stabilization and promote fusion within the intervertebral space. This fundamental principle is inherent to all devices in this product classification and is assumed to be similar to its predicates. The submission states that operational principles are similar. |
| Similar Material Composition (The materials used in the device should be the same or result in equivalent performance and biocompatibility as the predicate.) | While specific material composition is not detailed in the provided text, the submission states that the subject device is "substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition..." This implies that the materials used are either the same or have been assessed to be equivalent to those of the predicate devices. |
| Acceptable Performance via Non-Clinical Testing (Mechanical, biocompatibility, sterilization, and other relevant non-clinical tests demonstrating safety and effectiveness comparable to the predicate.) | Mechanical Testing: The STALIF™ TT was tested according to:ASTM F 2077-03 – Static and Dynamic TestsASTM F 2267-04 – Subsidence Test |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on engineering drawings and non-clinical mechanical testing, not a clinical "test set" of patient data.
- Data Provenance: Not applicable for a clinical test set. The mechanical testing standards (ASTM F 2077-03 and ASTM F 2267-04) are international standards. The origin of the actual test samples would likely be from the manufacturer (Surgicraft Limited, UK). The study is not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is Not Applicable as no clinical test set with ground truth established by medical experts was used or described. The "ground truth" in 510(k) for mechanical testing is adherence to the specified ASTM standards.
4. Adjudication Method for the Test Set
- Not Applicable. No clinical test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a medical device clearance, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" is defined by the ASTM standards (ASTM F 2077-03 for static and dynamic tests, and ASTM F 2267-04 for subsidence tests). The device's mechanical performance is compared against the requirements and typical performance characteristics for intervertebral fusion devices as outlined in these standards and generally accepted for substantial equivalence to predicate devices. There is no pathology, outcomes data, or expert consensus used as ground truth in the clinical sense for this submission.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device. The physical device is manufactured based on design specifications and then tested.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the word "SURGICRAFT" in bold, black letters. Above the word, there are three curved lines stacked on top of each other. The lines are also black and appear to be a stylized design element.
JUN - 4 2008
510 (k) Summary
| A | 510(k) Owner | Surgicraft Limited16 The OaksClews RoadRedditch, WorchesterEngland B98 7ST |
|---|---|---|
| Contact | Donald W. GuthnerOrgenix, LLC111 Hill RoadDouglassville, PA 19518(646) 460-2984(484) 363-5879 (FAX)dg@orgenix.com | |
| Preparation Date | May 15, 2008 | |
| B | Trade Name | STALIFT™ TT Intervertebral Body Fusion System |
| Common Name | Intervertebral Body Fusion Device | |
| Classification Name | 21 CFR 888.3080MAX - Intervertebral body fusion deviceClass II | |
| C | Predicate Device(s) | The subject device is substantially equivalent to similarpreviously cleared devices. Substantial equivalence for theSurgicraft STALIFTM TT is based on its similarities inindications for use, design features, operational principlesand material composition when compared to the predicatedevices cleared under the following submissions:• K080083 - Intrepid™ Spinal System Device,Medtronic Sofamor Danek, USA• K051027, K041617 - STALIFTM TT Vertebral BodyReplacement Device, Surgicraft Limited• K072415 - STALIFT™ C Intervertebral Body FusionDevice, Surgicraft Limited• P970015, S022 - LT-Cage Lumbar Tapered FusionDevice, Medtronic Sofamor Danek, USA |
Surgicraft Limited / 16 The Oaks / Clews Road / Redditch / Worcestershire / UK / BBB 7ST
Tel: +44 (0)1527 512600 / Fax: +44 (0)1527 651166 / Customer Service Fax: +44 (0)1527 512612 / B-mail: info@surgicaal.co.k
www.surgicraft.co.uk
Reightered Citilia 16 This Osloss Purch Redulets Woroestarstare (1K Bail TST Frightfer 39264)
App. 1-16
:
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- The Surgicraft STALIF"M TT is a radiolucent intervertebral D Device Description body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM TT is similar to that of the vertebral body endplate with a central cavity than can be packed with bone graft (autograft). The STALIFTMTT IBF System consists of varying sizes to include different widths, heights and hole positions to accommodate individual pathology and anatomical conditions.
- The STALIFTM TT Intervertebral Body Fusion System is E Intended Use indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved DDD is defined as discogenic back pain with levels. degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach..
The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIFTM TT system may be used with bone grafting material (autograft only).
As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.
Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
- F Technological Characteristics
App. 1 - 17
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| G | Non-Clinical Testing | As recommended by the Guidance Document, the STALIFTMTT was tested as follows:• Mechanical Testingo ASTM F 2077-03 – Static and Dynamic Testso ASTM F 2267-04 – Subsidence Test |
|---|---|---|
| H | Clinical Testing | Not applicable to this device |
| I | Conclusions | Based on the 510(k) Summary and the information providedherein, we conclude that the Surgicraft STALIFTMTT issubstantially equivalent to the existing legally marketeddevices under the Federal Food, Drug and Cosmetic Act. |
| J | Additional Information | No additional information |
:
:
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgicraft Limited % Orgenix, LLC Mr. Donald W. Guthner 111 Hill Road Douglassville, PA 19518
SEP 12 2011
Re: K073109
Trade/Device Name: Stalif™ TT Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 15, 2008 Received: May 20, 2008
Dear Mr. Guthner:
This letter corrects our substantially equivalent letter of June 4, 2008.
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 (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 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
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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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Sincerely yours,
Mark A. Mulkersen
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: STALIFTM TT Intervertebral Body Fusion System
Indications for Use:
The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIFTM TT system may be used with bone grafting material (autograft only).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.R. dgh for mxm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K073109
§ 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.