(150 days)
P980048 S003, P000028, K071833
Not Found
No
The document describes a physical intervertebral body fusion cage and its intended use, materials, and testing, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is described as an intervertebral body fusion cage intended for the treatment of cervical degenerative disc disease. This indicates it is used for medical therapy.
No
The device is an intervertebral body fusion cage intended for treatment of cervical degenerative disc disease by facilitating fusion, not for diagnosing a condition.
No
The device description clearly states it is a physical intervertebral body fusion device made of PEEK-Optimad LTI, along with bone screws. It is a hardware implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is inserted into the body to treat a physical condition (degenerative disc disease).
- Device Description: The description details a physical implant made of PEEK and bone screws.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is implanted inside the body.
N/A
Intended Use / Indications for Use
The STALIF C is intended to be used as an intervertebral body fusion cage as a stand alone system used with the bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 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 to facilitate fusion. STALIFTM C is intended to be used at one level. 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.
Product codes
OVE
Device Description
STALIFTM C 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 C is similar to that of the vertebral body endplate with a central cavity that can be packed with autograft. STALIFTM C is manufactured from PEEK-Optimad LTI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, levels C2 to T1
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)
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.
Non-Clinical Testing:
ASTM 2077-03
ASTM F2267-04
ASTM F1877-98(03)
H Clinical Testing: Not applicable to this device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P980048 S003, P000028, K071833
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the word "SURGICRAFT" in a bold, stylized font. Above the word, there are three curved lines stacked on top of each other. The lines appear to be a design element or logo associated with the word.
510 (k) Summary -- K072415
| A | 510(k) Owner | Surgicraft Limited
16 The Oaks
Clews Road
Redditch, Worchester
England B98 7ST
JAN 25 2008 |
|---|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact | Donald W. Guthner
Orgenix, LLC
111 Hill Road
Douglassville, PA 19518
(646) 460-2984
(484) 363-5879 (FAX)
dg@orgenix.com |
| | Preparation Date | December 7, 2007 |
| B | Trade Name | STALIFT™ C |
| | Common Name | Intervertebral Body Fusion Device, IBF Device |
| | Classification Name | Intervertebral Body Fusion Device |
| C | Predicate Device(s) | Substantial equivalence for the Surgicraft STALIFT™ C is
based on its similarities in indications for use, design
features, operational principles and material composition
when compared to the predicate devices cleared under the
following submissions:
• P980048 S003 BAK/C Vista Cervical Interbody
Fusion Device, Zimmer Spine, USA
• P000028 AFFINITY Anterior Cervical Cage System
Medtronic Sofamor Danek, USA
• K071833 Mosaic Device (a PEEK Cervical IBF |
device), Spinal Elements, İnc.
.
Surgicraft Limited / 16 The Caks / Clews Road / Reddich / Worcestershire : UK / 898 7ST Tel: +44 (0)1527 512600 : Fax: +44 (0)1527 551166 : Customer Service Fax: +44 (0)1527 512612 / E-mail: inlo@gurgica1.co uk www.surgicraft.co.uk
Media - The Finis Class (1) 49 Million Media Specifica (1, 109 70) Repear Maper (18 w
l
1
STALIFTM C is a radiolucent intervertebral body fusion Device Description D 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 C is similar to that of the vertebral body endplate with a central cavity that can be packed with autograft. STALIFTM C is manufactured from PEEK-Optimad LTI.
- The STALIF C is intended to be used as an intervertebral E Intended Use body fusion cage as a stand alone system used with the bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 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 to facilitate fusion. STALIFTM C is intended to be used at one level. 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.
- F As was established in this submission, the subject device is Technological Characteristics 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.
- G Non-Clinical Testing FDA Recognized Performance Standards
-
- ASTM 2077-03
- · ASTM F2267-04
- · ASTM F1877-98(03)
-
- Not applicable to this device H Clinical Testing
- Based on the 510(k) Summary and the information provided l Conclusions herein, we conclude that the Surgicraft STALIFTM C is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.
- J Additional Information NA
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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are 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, Ltd % Orgenix, LLC Mr. Donald Guthner 111 Hill Road Douglassville, PA 19518
SEP 12 2011
Re: K072415
Trade/Device Name: STALIFTM C Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 17, 2007 Received: December 19, 2007
Dear Mr. Guthner:
This letter corrects our substantially equivalent letter of January 25, 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
3
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Made A. Mikkelsen
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: STALIFTM C
Indications for Use:
The STALIF C is intended to be used as an intervertebral body fusion cage as a stand alone system used with the bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative 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 nutograft bone to facilitate fusion. STALIFTM C is intended to be used at one level.
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.
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)
Mark A. Milken
ivision Sign-Off Division of General, Restorative, and Neurological
Page of of
510(k) Number