(121 days)
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No
The document describes a physical implant (cervical and lumbar cages) made of PEEK polymer, intended for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The function is purely mechanical (maintaining disc space).
Yes.
The device is used to facilitate intervertebral body fusion to treat degenerative disc disease, which is a medical condition.
No.
The device (Fusion Advantage Cervical/Lumbar Cages) is an intervertebral body fusion device designed to facilitate spinal fusion and maintain disc space, not to diagnose a condition.
No
The device description clearly describes a physical implant made of PEEK polymer, intended for surgical implantation. It 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 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 Fusion Advantage Cervical and Lumbar Cages are implants designed to be surgically placed in the spine to facilitate intervertebral body fusion. They are physical devices used within the body, not for testing samples outside the body.
- Function: The stated function is "To maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion," which is a mechanical function within the body.
Therefore, the Fusion Advantage Cervical and Lumbar Cages are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Fusion Advantage Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Fusion Advantage Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at over wo contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Fusion Advantage Lumbar Cage implants are to be used with autogenous bone graft and implanted via an open posterior, transforaminal or lateral approach. The Fusion Advantage Lumbar Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Product codes
ODP, MAX
Device Description
The Adaptive Specialty Fusion Advantage cervical cage was developed as an intercorporal implant for anterior cervical spondylodesis. The Fusion Advantage System was especially adapted to the local anatomy in order to secure the surgical result as well as possible. Its inferior and superior sides are flat with ridges on both surfaces to prevent migration. The implant is oval shaped with a large central graft space to help facilitate bony integration once implanted. In the lateral view, the implant has a 2.5° lordotic form.
The Adaptive Specialty Fusion Advantage Lumbar cage was developed as an implant for the posterior stabilization of the lumbar spinal column. The Adaptive Specialty Fusion Advantage implant has ridges on both its inferior and superior surfaces to prevent migration. It is a rectangular shape with a large rectangular graft space and lateral holes help facilitate bony integration once implanted.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine (C3 to C7 disc levels), lumbar spine (L2-S1)
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests performed according to ASTM F2077/F2267 indicate that the Interbody Fusion Advantage Interbody Cages meet required mechanical strengths.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) Summary for the Fusion Advantage Interbody Cages
MAR 2 0 2009
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Fusion Advantage Interbody Cages
Date Prepared: February 12, 2008
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- Submitter: Adaptive Specialty, LLC
25 NW 23rd PL, STE 6 - 347 Portland, OR 97210
- Submitter: Adaptive Specialty, LLC
Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock. TX 78681 Telephone: 512-388-0199
MAR 1 2009
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- Trade name: Fusion Advantage Interbody Cages Common Name: intervertebral body fusion device Classification Name: intervertebral body fusion device - cervical Intervertebral body fusion device - lumbar 21 CFR section 888.3080 ODP/MAX Class II
ന് Predicate or legally marketed devices which are substantially equivalent:
The Fusion Advantage Interbody Cages are substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.
4. Description of the device:
The Adaptive Specialty Fusion Advantage cervical cage was developed as an intercorporal implant for anterior cervical spondylodesis. The Fusion Advantage System was especially adapted to the local anatomy in order to secure the surgical result as well as possible. Its inferior and superior sides are flat with ridges on both surfaces to prevent migration. The implant is oval shaped with a large central graft space to help facilitate bony integration once implanted. In the lateral view, the implant has a 2.5° lordotic form.
The Adaptive Specialty Fusion Advantage Lumbar cage was developed as an implant for the posterior stabilization of the lumbar spinal column. The Adaptive Specialty Fusion Advantage implant has ridges on both its inferior and superior surfaces to prevent migration. It is a rectangular shape with a large rectangular graft space and lateral holes help facilitate bony integration once implanted.
Materials:
PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)
Function:
To maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.
ട്. Intended Use:
Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Fusion Advantage Cervical Cages are to be used with
1
Image /page/1/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K083425". The characters are written in a simple, slightly irregular style, typical of handwriting. The contrast is high, with dark characters against a light background, making the string easily readable.
supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Fusion Advantage Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at over wo contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Fusion Advantage Lumbar Cage implants are to be used with autogenous bone graft and implanted via an open posterior, transforaminal or lateral approach. The Fusion Advantage Lumbar Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
The Fusion Advantage Interbody Cages have the same indications and material, and similar designs as previously cleared devices.
7. Summary of Nonclincal Tests
Tests performed according to ASTM F2077/F2267 indicate that the Interbody Fusion Advantage Interbody Cages meet required mechanical strengths.
Image /page/1/Picture/7 description: The image contains handwritten text. The text includes the abbreviation "iva" at the top, followed by "py" and "3 of 2" on the next line. The handwriting appears to be in black ink on a white background.
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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Adaptive Specialty, LLC % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681 .
MAR 2 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K083425
Trade/Device Name: Fusion Advantage Cervical Cages, Fusion Advantage Lumbar Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP, MAX Dated: February 19, 2009 Received: February 19, 2009
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 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. J.D. Webb
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mollen
Mark N. Melkerson 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
510(k) Number (if known): K083425
Device Name: Fusion Advantage Cervical Cages
Indications for Use:
Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radioular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Fusion Advantage Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Prescription Use × (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)
(Division Sign-6 Division of General, Restorative, and Neurological Devices
510(k) Number K083428
5
Indications for Use
510(k) Number (if known): K06342 S
Device Name:
Indications for Use:
The Fusion Advantage Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the fumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Fusion Advantage Lumbar Cage implants are to be used with autogenous bone graft and implanted via an open posterior, transforaminal or an lateral approach. The Fusion Advantage Lumbar Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous nonfusion 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)