(88 days)
Not Found
No
The document describes a spinal implant and a surgical system, but there is no mention of AI or ML technology in the intended use, device description, or performance studies. The mention of the "Accuvision System" for minimally invasive surgery does not inherently imply AI/ML; it likely refers to a visualization or navigation system.
Yes
The device is indicated for vertebral body replacement and intervertebral fusion to treat diseases like tumors, restore height of collapsed vertebral bodies, and treat fractures, which are all therapeutic interventions.
No
The device description and intended use indicate it is an implant for spinal fusion and vertebral body replacement, not for diagnosing conditions.
No
The device description explicitly states the device is constructed of Titanium alloy or PEEK, indicating it is a physical implant, not software only.
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.
- Ibex™ Spinal System Function: The description clearly states the Ibex™ Spinal System is a physical implant used for vertebral body replacement and intervertebral fusion. It is a structural device implanted into the body to treat spinal conditions.
- Lack of Diagnostic Testing: The intended use and device description do not mention any form of testing on biological samples or providing diagnostic information.
The Ibex™ Spinal System is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Ibex™ Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Ibex™ is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Ibex™ Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The IbexTM Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time.
As an intervertebral body fusion device, the Ibex™ Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Ibex™ Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Ibex™ Spinal System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterolateral spinal surgery.
Product codes
MAX, MQP
Device Description
The Ibex "Spinal Spacer is a curved device constructed of either Titanium alloy or medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T1- L5), thoracic and lumbar spine, lumbar spine from L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Based upon the mechanical testing, Ibex™ Spinal System is substantially equivalent for its intended use to other spacers currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040928, K082406, K042268, K050861
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/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in all caps and in a bold, sans-serif font. The word "SPINE" is in a smaller, sans-serif font and is located below the word "BIOMET". The logo is black and white.
510(k) Summary
| Preparation Date: | August 6, 2009 | AUG 07 2009 |
|---|---|---|
| Applicant/Sponsor: | Biomet Spine | |
| 100 Interpace Parkway | ||
| Parsippany, NJ 07054 | ||
| Contact Person: | Vivian Kelly | |
| Phone: 973-299-9300 | ||
| Fax: 973-257-0232 | ||
| Trade name: | Ibex™ Spinal System | |
| Common Name: | Non-cervical spinal spacer | |
| Classification Name: | Intervertebral fusion device, 21 CFR §888.3080 | |
| Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 | ||
| Device Panel /Product Code: | Orthopedic MAX & MQP |
Device Description:
The Ibex "Spinal Spacer is a curved device constructed of either Titanium alloy or medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.
Indications for Use:
The Ibex™Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Ibex™Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- LS) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Ibex™ Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The Ibex™ Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time.
As an intervertebral body fusion device, the Ibex™ Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
The Ibex™ Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Ibex™ Spinal System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.
Summary of Technologies:
The technological characteristics (material, design and sizing) of the Ibex " Spinal Spacer is the same as, or similar to, the predicate devices.
Substantial Equivalence:
The Ibex™ Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406) and the Ibex™ Spinal System (K042268 & K050861) has similar design features. Based upon the mechanical testing, Ibex™ Spinal System is substantially equivalent for its intended use to other spacers currently on the market.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, using a black and white color scheme.
AUG 0 7 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Spine % Ms. Vivian Kelly Regulatory Affairs Manager 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K091381
Trade/Device Name: IBEX™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: May 8, 2009 Received: May 11, 2009
Dear Ms. Kelly:
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.
2
Page 2 - Ms. Vivian Kelly
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/CDRH0ffices/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkersc 11 Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: IbexTM Spinal System
Indications for Use:
The Ibex™ Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Ibex™ is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Ibex™ Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The IbexTM Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time.
As an intervertebral body fusion device, the Ibex™ Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Ibex™ Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Ibex™ Spinal System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterolateral spinal surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
18-1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2_Z, (EXT for MYCM)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_KO91381