(213 days)
The provided text does not contain any K/DEN numbers for predicate devices.
Not Found
No
The provided text describes a physical implant (intervertebral body fusion cage) and its intended use and mechanical properties. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is an implant for intervertebral body fusion to treat degenerative disc disease and radicular symptoms, which directly addresses a medical condition to restore function.
No
The provided text describes the ORIO Cervical and Lumbar Intervertebral Body Fusion Cages as implants used for spine stabilization and fusion. The device does not perform any diagnostic function; rather, it is a treatment device.
No
The device description clearly states that the ORIO Intervertebral Body Fusion Cages are implants, which are physical hardware devices. The summary also mentions mechanical strength testing, further indicating a 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ORIO Cervical and Lumbar Intervertebral Body Fusion Cages are described as implants for the stabilization of the spinal column. They are surgically placed within the body.
- Intended Use: The intended use is to facilitate intervertebral body fusion in the cervical and lumbar spine in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
ORIO Cervical Intervertebral Body Fusion 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. ORIO Cervical Intervertebral Body Fusion Cages 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. ORIO Cervical Intervertebral Body Fusion 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 ORIO Lumbar Intervertebral Body Fusion 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. Degeneralive 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 at the involved level(s). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO Lumbar Intervertebral Body Fusion 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, ODP
Device Description
The ORIO Intervertebral Body Fusion Cages were developed as implants for the stabilization of the lumbar spinal column and anterior cervical spondylodesis. The ORIO implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Summary of Non-clinical Tests
mary of Not of Not of Not F2077/F2267 indicate that the ORIO Intervertebral Body Fusion Cages meet required mechanical strengths. Some of the predicate devices have a different geometry than the ORIO Intervertebral Body Fusion Cages and do not have some test results reported in their PMA and 510(k) summaries, therefore, additional acceptance values for testing have been utilized.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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.
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K040887
510(k) Summary for the ORIO Intervertebral Body Fusion Cages
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ORIO Intervertebral Body Fusion Cages.
Date Prepared: March 24, 2009
| 1. | Submitter:
SpineCraft LLC
2215 Enterprise Drive
Westchester, IL 60154 | Contact Person:
J.D. Webb
The OrthoMedix Group, Inc.
1001 Oakwood Blvd
Round Rock, TX 78681
Telephone: 512-388-0199 | OCT 3 0 2005 |
|----|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 2. | Trade name: | - ORIO-C Intervertebral Body Fusion Cervical Cage
- ORIO-PL PLIF Intervertebral Body Fusion Lumbar Cage
- ORIO-TL TLIF Intervertebral Body Fusion Lumbar Cage
- ORIO-AL ALIF Anterior/Anterolateral Intervertebral Body Fusion
Lumbar Cage | |
| | Common Name:
Classification Name: | intervertebral body fusion device
intervertebral body fusion device - cervical
Intervertebral body fusion device - lumbar
21 CFR section 888.3080
ODP/MAX
Class II | |
Predicate or legally marketed devices which are substantially equivalent: 3.
ORIO Intervertebral Body Fusion Cages are substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.
Description of the device: ব
The ORIO Intervertebral Body Fusion Cages were developed as implants for the stabilization of the lumbar spinal column and anterior cervical spondylodesis. The ORIO implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.
Materials:
PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)
Intended Use: ട.
ORIO Cervical Intervertebral Body Fusion 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. ORIO Cervical Intervertebral Body Fusion Cages 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. ORIO Cervical Intervertebral Body Fusion 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 ORIO Lumbar Intervertebral Body Fusion 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. Degeneralive 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 at the involved
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level(s). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO Lumbar Intervertebral Body Fusion 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.
Comparison of the technological characteristics of the device to predicate and legally 6. marketed devices:
The ORIO Intervertebral Body Fusion Cages have the same indications and material, and similar designs as previously cleared devices.
7. Summary of Non-clinical Tests
mary of Not of Not of Not F2077/F2267 indicate that the ORIO Intervertebral Body Fusion Cages meet required mechanical strengths. Some of the predicate devices have a different geometry than the ORIO Intervertebral Body Fusion Cages and do not have some test results reported in their PMA and 510 (k) summaries, therefore, additional acceptance values for testing have been utilized.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem of a stylized caduceus, a symbol often associated with medicine and healthcare. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The emblem and text are in a blue color.
DEC 16 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SpineCraft, LLC % Mr. J.D Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock. Texas 78681
Re: K090887
Trade/Device Name: ORIO-C Intervertebral Body Fusion Cervical Cage ORIO-PL PLIF Intervertebral Body Fusion Lumbar Cage ORIO-TL TLIF Intervertebral Body Fusion Lumbar Cage ORIO-AL ALIF Anterior/Anterolateral Intervertebral Body Fusion Lumbar Cage
Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: October 30, 2009 Received: October 30, 2009
Dear Mr. Webb:
This letter corrects our substantially equivalent letter of October 30. 2009.
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 Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2- Mr. J.D. Webb
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,
Mark n millerm
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): _KO90887
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The ORIO lumbar intervertebral body fusion 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 spondylolisthesis or retrolisthesis at the involved level(s). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO lumbar intervertebral body fusion 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 × (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)
Off
Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K090887
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Indications for Use
510(k) Number (if known): _KO90887
Device Name: ORIO cervical intervertebral body fusion cages
Indications for Use:
ORIO cervical intervertebral body fusion 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. ORIO cervical intervertebral body fusion cages used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 discliens using autograft bone. ORIO cervical intervertebral body fusion 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 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)
(Division Sign-Oii) Division of Surgical Orthopedic, and Restorative Devices
K090887 510(k) Number_
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