(315 days)
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Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an implant for intervertebral body fusion procedures to treat degenerative disc disease, which clearly indicates a therapeutic purpose.
No
Explanation: The device is an intervertebral body fusion cage, used for treating degenerative disc disease, not for diagnosing it. Its purpose is to physically stabilize the spine, not to detect or analyze medical conditions.
No
The device description clearly describes a physical implant made of PEEK polymer, which is a hardware component.
No, 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, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (a cage) used in spinal fusion procedures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "intervertebral body fusion procedures" and is "implanted via an open posterior approach." This is a surgical intervention, not a diagnostic test.
The device is a surgical implant used to treat a condition (degenerative disc disease) by providing structural support and promoting fusion, not to diagnose or monitor a condition through analysis of biological samples.
N/A
Intended Use / Indications for Use
The distractable WAVE PLIF Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar 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). Distractable WAVE PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The distractable WAVE PLIF 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.
Product codes
MAX
Device Description
The distractable WAVE cage is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6' lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs.
The distractable WAVE cage is different from the previously cleared WAVE by the ability to distract the implant and restore disc height.
Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lumbar spine at one or two contiguous levels from 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
Not Found
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 distractable WAVE cage meets 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.
0
510(k) Summary for the Distractable WAVE Cage
OCT 1 7 2009
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Distractable WAVE Cage.
Date Prepared: December 1, 2008
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- Submitter: Advanced Medical Technologies Kasteler Str. 11 66620 Nonnweiler GERMANY
Contact Person:
- Submitter: Advanced Medical Technologies Kasteler Str. 11 66620 Nonnweiler GERMANY
J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blyd Round Rock, TX 78681 Telephone: 512-388-0199
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- Trade name: Common Name: Classification Name:
Distractable WAVE cage intervertebral body fusion device intervertebral body fusion device - lumbar 21 CFR section 888.3080 MAX Class II
- Trade name: Common Name: Classification Name:
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- Predicate or legally marketed devices which are substantially equivalent:
The distractable WAVE cage is substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.
- Predicate or legally marketed devices which are substantially equivalent:
4. Description of the device:
The distractable WAVE cage is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6' lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs.
The distractable WAVE cage is different from the previously cleared WAVE by the ability to distract the implant and restore disc height.
Materials:
PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications).
5. Intended Use:
The distractable WAVE PLIF Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar 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). Distractable WAVE PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The distractable WAVE PLIF 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.
ల్ Comparison of the technological characteristics of the device to predicate and legally marketed devices:
The distractable WAVE cage has 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 distractable WAVE cage meets required mechanical strengths.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of a staff with a snake coiled around it, and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Medical Technology, Inc. % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K083626
Trade/Device Name: Distractable WAVE PLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: MAX Dated: September 15, 2009 Received: September 21, 2009
OCT 1 7 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 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 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
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 yours,
Mark M. Milliman
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: _ Distractable WAVE PLIF Cage
Indications for Use:
The distractable WAVE PLIF Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar 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). Distractable WAVE PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The distractable WAVE PLIF 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.
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)
Mark A. Millum
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083626