(84 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a cervical plate system, with no mention of AI or ML technologies.
Yes
The device is described as "intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD)... spondylolisthesis, trauma... spinal stenosis, deformities or curvatures... tumor, pseudoarthrosis, and failed previous fusion." This directly indicates its use in treating medical conditions, fitting the definition of a therapeutic device.
No
Explanation: The device is a cervical plate system used for anterior cervical fixation in various spinal conditions. Its purpose is to stabilize the spine, not to diagnose medical conditions or identify diseases.
No
The device description clearly states that the system consists of physical components (plates and screws) made from Titanium alloy and Nitinol, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that the Pioneer Poise Anterior Cervical Plate System consists of plates and screws used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. This is an implantable surgical device used inside the body.
- Intended Use: The intended use describes the conditions for which the device is used for anterior cervical fixation, which is a surgical procedure.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Pioneer Poise Anterior Cervical Plate System is 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 (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Pioneer Poise Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The Poise system consists of static and dynamic plates in lengths that range from 10-84mm and include one, two, three and four level designs. The dynamic design provides for uni-directional axial movement for postoperative load sharing between the plate and graft. The plates have an integrated screw retention mechanism. Screws range from 10-20mm in length, 4.0 or 4.5mm in diameter, and are available in self tapping or self drilling. The plates and screws are manufactured from Titanium alloy (ASTM F136) and Nitinol (ASTM F2063).
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 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)
Non-Clinical Mechanical testing was presented to characterize construct and component performance, including testing static and fatigue compression bending and static torsion per recognized ASTM F1717, axial pullout screw strength per ASTM F543, and additional testing performed per internal protocols to assess screw pull through plate and screw retention characteristics. The test results of verification testing demonstrate that the mechanical performance of the Pioneer Poise Anterior Cervical Plate System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K083663, K072703, K053053, K043066
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
| Sponsor: | JUN - 4 2010
Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855
(906) 225-5602
Contact: Emily M. Downs
Prepared May 20, 2010 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Pioneer Poise Anterior Cervical Plate System |
| Classification
Name: | The classification of the Pioneer Poise Anterior Cervical Plate System is
Class II, as per the Code of Federal Regulations, Title 21, Section
888.3060: Spinal intervertebral body fixation orthosis. |
| Product Codes: | The product code is KWQ. The Panel code is 87. |
| Predicate Device: | K083663- Pioneer Anterior Cervical (PAC) Plate System (SE 2/25/09)
K072703- Pioneer SlimFuse Anterior Cervical Plating System (SE 1/10/08)
K053053- Pioneer Anterior Cervical Plate System (SE11/16/05)
K043066- Pioneer Anterior Cervical Plate System (SE 2/3/05) |
| Description: | The Pioneer Poise Anterior Cervical Plate System consists of an assortment
of plates and screws. The screws are used to secure the plates to the
vertebral bodies of the cervical spine through an anterior approach. The
Poise system consists of static and dynamic plates in lengths that range
from 10-84mm and include one, two, three and four level designs. The
dynamic design provides for uni-directional axial movement for
postoperative load sharing between the plate and graft. The plates have an
integrated screw retention mechanism. Screws range from 10-20mm in
length, 4.0 or 4.5mm in diameter, and are available in self tapping or self
drilling. The plates and screws are manufactured from Titanium alloy
(ASTM F136) and Nitinol (ASTM F2063). |
| | The system also contains Class 1 manual surgical instruments and cases
that are considered exempt from premarket notification. |
| Intended Use: | The Pioneer Poise Anterior Cervical Plate System is 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. |
1
The subject device has indications for use identical to those of the predicate Comparison to Predicate Devices: PAC system and employs the same principles of operation. Identical materials are used for both subject and predicate plates and screws. A vailable screw lengths (10-20mm), screw diameters (4.0/4.5mm), overall plate length (10-84mm), and plate types (one, two, three and four level; static and dynamic) are identical for both systems.
The Pioneer Poise Anterior Cervical Plate System plates and screws are Material: manufactured from titanium alloy (Ti6Al4V ELI, according to ASTM The plates incorporate a screw-retention mechanism ("spring"), F136). which is manufactured from Nitinol (ASTM F2063).
Non-Clinical Mechanical testing was presented to characterize construct and component performance, including testing static and fatigue compression bending and Performance Data: static torsion per recognized ASTM F1717, axial pullout screw strength per ASTM F543, and additional testing performed per internal protocols to assess screw pull through plate and screw retention characteristics. The test results of verification testing demonstrate that the mechanical performance of the Pioneer Poise Anterior Cervical Plate System is substantially equivalent to the predicate devices.
Comparisons of device performance data, materials, indications and Performance and design/function to predicate devices were provided in making a SE Determination: determination of substantial equivalence.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 4 2010
Pioneer Surgical Technology % Ms. Emily M. Downs 375 River Park Circle Marquette, Michigan 49855
Re: K100708
Trade/Device Name: Pioneer Poise Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 13, 2010 Received: April 14, 2010
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 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 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
3
Page 2 - Ms. Emily M. Downs
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark M. Mulkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K100708
-Device-Name:
Indications for Use:
The Pioneer Poise Anterior Cervical Plate System is 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
Pioneer-Poise Anterior Cervical Plate
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
failed previous fusion.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
K100708 510(k) Number_