(108 days)
Not Found
No
The 510(k) summary describes a mechanical implant system (plates and screws) for spinal fusion and does not mention any software, algorithms, or AI/ML components.
Yes
The device is described as an "Anterior Cervical Plating System" intended for "anterior cervical fixation as an adjunct to cervical fusion" for various medical conditions, indicating it directly treats or alleviates a diseased or injured condition.
No
Explanation: The device is an anterior cervical plating system intended for fixation as an adjunct to cervical fusion. It is a surgical implant used for treatment, not for diagnosing a condition.
No
The device description explicitly states it consists of plates, screws, and surgical instruments, which are hardware components.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the Pioneer SlimFuse Anterior Cervical Plating System consists of "an assortment of plates and screws" and "manual surgical instruments." These are physical implants and tools used during surgery on the body, not for testing samples outside the body.
- Intended Use: The intended use describes the system's purpose as "anterior cervical fixation as an adjunct to cervical fusion." This is a surgical procedure to stabilize the spine, not a diagnostic test.
The information provided describes a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Pioneer SlimFuse Anterior Cervical Plating System intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The Pioneer SlimFuse Anterior Cervical Plating System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical region of the spine
Indicated Patient Age Range
Not Found
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)
Testing per recognized ASTM standards was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Pioneer SlimFuse Anterior Cervical Plating System
3.0 510(k) Summary
| Sponsor: | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855
(906) 226-4812
Contact: Jonathan M. Gilbert | JAN 10 2008 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name: | Pioneer SlimFuse Anterior Cervical Plating System | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II. | |
| Classification Number: | Regulation Number: 888.3060
Product Code: KWQ
Panel Code: 87 | |
| Predicate Devices: | K040366
K053053
K042544 | |
| Description: | The Pioneer SlimFuse Anterior Cervical Plating System
consists of an assortment of plates and screws. The
system also contains Class 1 manual surgical instruments
and cases that are considered exempt from premarket
notification. | |
| Intended Use: | The Pioneer SlimFuse Anterior Cervical Plating System
intended for anterior cervical fixation for the following
indications: degenerative disc disease (DDD) (defined as
neck pain of discogenic origin with degeneration of the
disc confirmed by history and radiographic studies),
spondylolisthesis, trauma (i.e., fracture or dislocation),
spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and
failed previous fusion. | |
| Material: | Materials (Ti 6A1 4V ELI) used to manufacture the
implants and instruments of this system are in
conformance with ASTM Standard Specifications. | |
| Performance Data: | Testing per recognized ASTM standards was presented. | |
| Performance and SE
Determination: | Comparisons of device performance data, materials,
indications and design/function to predicate devices were
provided in making a determination of substantial
equivalence. | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three overlapping wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JAN 10 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pioneer Surgical Technology % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, MI 49855
Re: K072703
Trade/Device Name: Pioneer SlimFuse Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 14, 2007 Received: December 17, 2007
Dear Mr. Gilbert:
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 such 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); 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 – Mr. Jonathan M. Gilbert
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
2.0 Indications for Use Statement
K072703 510(k) Number (if known):
Device Name:
Pioneer SlimFuse Anterior Cervical Plating System
Indications:
The Pioneer SlimFuse Anterior Cervical Plating System is intended for anterior cervical fixation as an adjunct to cervical fusion for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use (Per 21 CFR 801.109)
Over-the
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbave Pouellm
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K02703