(274 days)
Not Found
No
The description focuses on the material, shape, and mechanical properties of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in cervical interbody fusion procedures for patients with degenerative disc disease, aiming to provide structural stability and aid in spinal fixation. This aligns with the definition of a therapeutic device as something used to treat or alleviate a disease or condition.
No
The device is an interbody fusion device designed for structural support in spinal fusion procedures, not for diagnosing medical conditions. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is "Machined from medical grade PEEK-OPTIMA®" and is a physical "cervical interbody fusion device designed to be inserted within the intervertebral disc space". This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, not a test performed on biological samples outside the body to diagnose or monitor a condition.
- Device Description: The device is described as a physical implant made of PEEK, designed to provide structural stability in the spine.
- Performance Studies: The performance studies listed are bench tests evaluating the mechanical properties of the implant, not studies evaluating the accuracy of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant used in a surgical procedure.
N/A
Intended Use / Indications for Use
ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.
Product codes
ODP
Device Description
ORTHOVITA PEEK SPACER is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an aid in spinal fixation. Machined from medical grade PEEK-OPTIMA®, the device is trapezoidal in shape with a hollow frame to accept autogenous bone graft. ORTHOVITA PEEK SPACER is available in a range of heights and geometries to accommodate individual pathologies and anatomical conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (C2-C7)
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
The below list of preclinical bench testing was performed on the ORTHOVITA PEEK SPACER. The acceptance criteria of all tests were met.
- Static and dynamic axial compression, and static and dynamic torsion in accordance with ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
- Static subsidence testing in accordance with ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
Key Metrics
Not Found
Predicate Device(s)
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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510(k) SUMMARY ORTHOVITA PEEK SPACER
November 19, 2010
JAN 2 5 2011
510(k) Number (if known): K101171
1. Contact Person
Catherine Moffa, M.S. Director, Regulatory Affairs (e-mail) cmoffa@orthovita.com
Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 610-640-1714
2. Device Name and Classification
| Product Name: | ORTHOVITA PEEK SPACER |
|---|---|
| Classification Name: | Intervertebral body fusion device with bone graft, cervical |
| Common or Usual Name: | Intervertebral body fusion device |
| Classification Panel: | Orthopedic |
| Regulation Number: | 888.3080 |
| Device Class: | Class II |
| Product Code: | ODP |
3. Predicate Device(s)
Choice Spine's Cervical Interbody Spacer and System (K091531)
4. Device Description
ORTHOVITA PEEK SPACER is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an aid in spinal fixation. Machined from medical grade PEEK-OPTIMA®, the device is trapezoidal in shape with a hollow frame to accept autogenous bone graft. ORTHOVITA PEEK SPACER is available in a range of heights and geometries to accommodate individual pathologies and anatomical conditions.
5. Indications for Use
ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.
6. Performance Data
The below list of preclinical bench testing was performed on the ORTHOVITA PEEK SPACER. The acceptance criteria of all tests were met.
- Static and dynamic axial compression, and static and dynamic torsion in accordance with ASTM F2077, 트 Test Methods for Intervertebral Body Fusion Devices
- Static subsidence testing in accordance with ASTM F2267, Standard Test Method for Measuring Load I Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
7. Substantial Equivalence
Information within this submission supports substantial equivalence.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthovita, Inc. % Ms. Catherine Moffa, M.S. Director, Regulatory Affairs 45 Great Valley Parkway Malvern, Pennsylvania 19355
JAN 2 5 201
Re: K101171
Trade/Device Name: Orthovita Peek Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 20, 2010 Received: January 21, 2011
Dear Ms. Moffa:
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. 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 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
2
Page 2 – Ms. Catherine Moffa, M.S.
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.
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/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.lda.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.
y yours,
Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K101171
Device Name: ORTHOVITA PEEK SPACER
Indications for Use:
ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.
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 IF NEEDED)
X
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off (Division Sign-On)
Division of Surgic: ) Orthopedic,
Division of Surgic: Douices Division of Surgers -
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510(k) Number .