(130 days)
No
The document describes a physical implant (interbody cage) made of PEEK for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for spinal fusion procedures in patients with degenerative disc disease, acting as an intervertebral body fusion device to provide support and correction. This aligns with the definition of a therapeutic device as it is treating a medical condition.
No
This device is an implantable interbody fusion system designed to provide support for spinal fusion, not to diagnose a condition.
No
The device description clearly states that the device is an implantable cage made from PEEK, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the InterForm Lumbar Interbody Cage System is an implantable device made of PEEK, intended for surgical insertion between vertebral bodies to facilitate spinal fusion. It is a physical implant used in vivo (within the body), not a device used to analyze samples in vitro (outside the body).
The text focuses on the physical characteristics of the implant, its surgical application, and its function in providing structural support for fusion. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Product codes
MAX
Device Description
The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.
The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.
The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.
The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.
The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.
All implants are packaged non-sterile to be sterilized at the hospital.
Materials:
PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.
Function:
Maintain adequate disc space until fusion occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar or lumbosacral vertebral bodies)
Indicated Patient Age Range
Skeletally mature patients
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
Non-clinical tests were conducted: Static and dynamic compression per ASTM F2077, Subsidence per ASTM F2267, and Expulsion. No clinical studies were performed. The results indicate equivalence to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
DePuy, Brantigan I/F CAGE (P960025), SEASPINE, Pacifica Cage (K082310), DiFusion Technologies, XIPHOS Interbody Fusion System (K100042), Synthes T-PAL (K100089), Nuvasive CoRoent XL (K071795/ K081611), Medtronic Capstone (K073291), Synthes OPAL (K072791), GS Medical ANYPLUS (K100516), Medtronic Boomerang (K023570), Synthes Oracle (K062933), Spinal USA ShurFit (K092193), Amedica Valeo (K091278)
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
510(k) Summary for the InterForm Interbody Cage System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the InterForm Interbody Cage System
1. GENERAL INFORMATION
| Date Prepared: April 16, 2013 |
|---|
| Trade Name: InterForm Interbody Cage System |
| Common Name: intervertebral body fusion device |
| Classification |
| Name: Intervertebral body fusion device - lumbar |
| Class: II |
| Product Code: MAX |
| CFR section: 21 CFR section 888.3080 |
| Device panel: Orthopedic |
| Legally Marketed: Spinal Elements, Lucent Straight Interbody Cage (K071724/K081968) |
| Predicate Device: DePuy, Brantigan I/F CAGE (P960025) |
| SEASPINE, Pacifica Cage (K082310) |
| DiFusion Technologies, XIPHOS Interbody Fusion System (K100042) |
| Synthes T-PAL (K100089) |
| Nuvasive CoRoent XL (K071795/ K081611) |
| Medtronic Capstone (K073291) |
| Synthes OPAL (K072791) |
| GS Medical ANYPLUS (K100516) |
| Medtronic Boomerang (K023570) |
| Synthes Oracle (K062933) |
| Spinal USA ShurFit (K092193) |
| Amedica Valeo (K091278) |
| Submitter: Next OrthoSurgical |
| 3270 Corporate View, Suite A |
| Vista CA. 92081 |
| 760-295-3600 Tele |
| 760-295-3610 Fax |
| Contact: J.D. Webb |
| 1001 Oakwood Blvd |
| Round Rock, TX 78681 |
| 512-388-0199 Tele |
| 512-692-3699 Fax |
| e-mail: idwebb@orthomedix.net |
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2. DEVICE DESCRIPTION
The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.
The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.
The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.
The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.
The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.
All implants are packaged non-sterile to be sterilized at the hospital.
Materials:
PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.
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Function:
Maintain adequate disc space until fusion occurs.
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The InterForm Interbody Cage System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
4. INTENDED USE
When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
NON-CLINICAL TEST SUMMARY 5.
The following tests were conducted:
- . Static and dynamic compression per ASTM F2077
- Subsidence per ASTM F2267 .
- . Expulsion
The results of this testing indicate that the InterForm Interbody Cage System is equivalent to predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
Next OrthoSurgical considers the InterForm Interbody Cage System to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
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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-like symbol with three curved lines representing its wings or body. 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 Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2013
Next OrthoSurgical % Mr. J.D. Webb The OrthoMedix Group. Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K131082
Trade/Device Name: InterForm Lumbar Interbody Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 22, 2013 Received: July 31, 2013
Dear Mr. Webb:
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 10 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 cither 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 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
4
Page 2 - Mr. J.D. Webb
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): _ K131082
Device Name: __InterForm Lumbar Interbody Cage System
Indications for Use:
When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These palients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices