(135 days)
Not Found
No
The document describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for intervertebral body fusion of the spine and vertebral body replacement, treating conditions like cervical disc disease, degenerative disc disease, and tumors. These are all therapeutic actions aimed at treating a medical condition.
No
The device is an interbody fusion and vertebral body replacement system, which is a surgical implant used to replace or fuse parts of the spine. Its purpose is to restore spinal integrity and facilitate fusion, not to diagnose medical conditions.
No
The device description clearly states it consists of physical implants made from a radiolucent polymer (PEEK Optima®) and is used with surgical instruments. This indicates a hardware-based medical device, not software only.
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 and Intended Use: The description clearly states that this is an implantable device (Interbody Fusion / Vertebral Body Replacement System) used for spinal fusion and vertebral body replacement. It is surgically implanted into the patient's spine.
- Lack of Diagnostic Testing: There is no mention of this device performing any kind of test on biological samples to diagnose a condition. Its purpose is therapeutic and structural support.
Therefore, this device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.
When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.
When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) 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. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are 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. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.
Product codes
MAX, ODP, MQP
Device Description
The Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System consists of a variety of different footprints and heights which enable the surgeon to choose the implant best suited to an individual's pathology and anatomical condition. Supplemental anterior and/or posterior fixation is intended for use with the device to ensure stability of the spine and adequate compression of the implant. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique. The components are manufactured from a radiolucent polymer (PEEK Optima®) in order to allow radiographic imaging inside the implant to evaluate fusion status. The purpose of this submission to add implant configurations to the CrossFuse II line of implants, intended for lumbar IBF and VBR use. Class I (exempt) orthopedic manual surgical instruments, including the Clarity Retractor System, are also available for use with the System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from the C2-C3 disc to the C7-T1 disc, lumbar spine, from L2 to S1, thoracolumbar spine (T1-L5)
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
For a determination of substantial equivalence, static compression and static torsion testing was performed in accordance with ASTM F2077. In addition, static subsidence testing per ASTM F2267 and static expulsion testing per Draft Standard Z8423Z were performed. Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to a legally marketed predicate and sufficient for the intended use.
Key Metrics
Not Found
Predicate Device(s)
K112496, K133623, K073177, K043206, K061151, K071795
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
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.
:
| 510(k) Summary Pursuant to 21 CFR 807.92 | |
|---|---|
| Sponsor: | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) |
| 375 River Park Circle | |
| Marquette, MI 49855 USA | |
| Contact: Emily Downs, Sarah McIntyre | |
| Ph: (906) 225-5602 Fx: (906) 226-4459 | |
| Prepared: March 25, 2014 | |
| Name: | Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System |
| Trade names: | C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, & CrossFuse II |
| Common name: | Intervertebral Body Fusion Device/ Vertebral Body Replacement Device |
| Classifications: | 21 CFR 888.3080 - Class II . |
| 21 CFR 888.3060 - Class II | |
| Product Codes: | MAX, ODP, MQP |
| Panel/ Branch: | Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 |
| Predicates: | Pioneer IBF/VBR System K112496 &K133623 |
| Pioneer IBF System K073177 | |
| Pioneer VBR System K043206 & K061151 | |
| NuVasive CoRoent System (K071795) | |
| Description: | The Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System |
| consists of a variety of different footprints and heights which enable the | |
| surgeon to choose the implant best suited to an individual's pathology and | |
| anatomical condition. Supplemental anterior and/or posterior fixation is | |
| intended for use with the device to ensure stability of the spine and | |
| adequate compression of the implant. The IBF/VBR implants may be | |
| implanted via a variety or open or minimally invasive approaches, | |
| including anterior, lateral, posterior and oblique. | |
| The components are manufactured from a radiolucent polymer (PEEK | |
| Optima®) in order to allow radiographic imaging inside the implant to | |
| evaluate fusion status. | |
| The purpose of this submission to add implant configurations to the | |
| CrossFuse II line of implants, intended for lumbar IBF and VBR use. | |
| Class I (exempt) orthopedic manual surgical instruments, including the | |
| Clarity Retractor System, are also available for use with the System. |
:
1
Intended Use: When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.
When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.
When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) 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. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are 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. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.
2
| Pre-Clinical
Performance Data: | For a determination of substantial equivalence, static compression and
static torsion testing was performed in accordance with ASTM F2077. In
addition, static subsidence testing per ASTM F2267 and static expulsion
testing per Draft Standard Z8423Z were performed. Mechanical testing
showed that the mechanical strength of the subject system is substantially
equivalent to a legally marketed predicate and sufficient for the intended
use. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additional sizes and configurations outside the range of previously cleared
devices were justified based on an anatomic rationale. |
| Materials: | The Pioneer IBF/VBR System implants are composed of ASTM F 2026
Polyetheretherketone (PEEK) with ASTM F560 tantalum or ASTM F 136
Titanium alloy radiographic markers. |
| Summary of
Technological
Comparison: | The subject implants are unique from the predicate CrossFuse II implants
in that they include a coronal taper or increased lordotic angle
(hyperlordotic). |
| | This submission supports the position that the subject implants are
substantially equivalent to previously cleared IBF/VBR devices. The
subject and predicate devices are similar in terms of indications for use,
composition, sterilization, packaging,
material
technological
characteristics, design features, and mechanical strength. |
| Substantial
Equivalence | There are no significant differences between the subject and predicate
devices which would adversely affect the use of the product. Any
differences were not considered significant based on mechanical bench
testing. |
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G608 Silver Spring, MD 20993-0002
March 27, 2014
Pioneer Surgical Technology. Incorporated Ms. Emily Downs Director. Regulatory and Clinical Affairs 375 River Park Circle Marquette, Michigan 49855
Re: K133455
Trade/Device Name: Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX. ODP. MQP Dated: February 14, 2014 Received: February 18. 2014
Dear Ms. Downs:
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 mislcading.
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
4
Page 2 - Ms. Emily Downs
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 vour device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address -
http://www.fda.gov/McdicalDevices/Resourcesfor You/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/McdicalDevices/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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133455
Device Name
Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in paients who had six weeks of non-operative treatment. IBFs are with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level. such as Streamline OCT. SlimFuse, Cequence, PAC, or Aspect Systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
Contraction of the For For For For For For For For For Contract Comments of the Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Formitriev.
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133455
Device Name
Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System') is indicated for interverebral body fusion of the spine in skeletally mature patiented for use at either one level or two contiguous levels in the humbar spine, from L2 to S1, for the treatment of decement ve discase (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiosraphic studies. Lumbar IIIFFs are to be used in patients who have had six months of non-operative tecament. IBFs are designed for use with autogenous bour graft 10 facilitate fusion. 1895s are intended to be used with supplemental spinal fixation cleared level, such as Quantum. Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System,
Type of Use (Select one or both, as applicable)
[≥] Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
...
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133455
Device Name
Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
When used as a vertebral body replacement (VBR) device (C-Plus, Contact, CrossFuse, and CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System") is intended for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor of trauma of T1-L5) such as the Streamline TL Spinal Fixation System, Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CONTRACTOR COLLEGE FOR FOR EDAUSEIONLY AND THE FOR FOR FOR FOR FOR FOR FOR FOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)