(88 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implantable plate and screw system for spinal stabilization, functioning as an adjunct to fusion rather than directly delivering therapy.
No
The device is a surgical implant system intended to provide stabilization for spinal fusion, not to diagnose a condition.
No
The device description explicitly states it consists of plates, screws, and manual surgical instruments, which are physical hardware components.
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 system used to stabilize the lumbar and lumbosacral spine during fusion procedures. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details plates, screws, and surgical instruments made of titanium alloy. These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Pioneer Lumbar Plate 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. Implants are composed of titanium alloy Ti6Al4V (ISO 5832-3) ELI, the same as predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and lumbosacral (LI -S1) 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)
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff. Guidance for Spinal Systems 510(k')s", May 3, 2004 is presented. Comparisons of device performance data, materials, indications and design/function to predicate devices, K063158 &K041167, were provided in making a determination of substantial equivalence.
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.
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
Summary of Safety and Effectiveness Information . 3.0
| Sponsor: | Pioneer Surgical Technology
APR 2 8 2009
375 River Park Circle
Marquette, MI 49855
(906) 226-4812
Contact: Jonathan M. Gilbert |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Pioneer Lumbar Plate System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Number: | Regulation Number: 888.3060
Product Code: KWQ; Panel Code: 87 |
| Description: | The Pioneer Lumbar Plate 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. Implants are composed of titanium alloy
Ti6Al4V (ISO 5832-3) ELI, the same as predicate device. |
| Intended Use: | The Pioneer Lumbar Plate System is intended for use via the
lateral or anterolateral surgical approach above the bifurcation of
the great vessels or via the anterior surgical approach, below the
bifurcation of the great vessels. The Pioneer Lumbar Plate
System is indicated as an adjunct to fusion in the treatment of
lumbar and lumbosacral (LI -S1) spine instability as a result of
the following: fracture (including dislocation and subluxation),
tumor, degenerative disc disease (defined as back pain of
discogenic origin with degeneration of the disc confirmed by
patient history and radiographic studies), pseudoarthrosis,
spondylolysis, spondylolisthesis, scoliosis, lordotic deformities
of the spine, spinal stenosis, and failed previous spine surgery.
Warning: This device is not intended for screw attachment or
fixation to the posterior elements (pedicles) of the cervical,
thoracic, or lumbar spine. |
| Performance Data:
Performance and SE
Determination: | Mechanical testing in accordance with the "Guidance for
Industry and FDA Staff. Guidance for Spinal Systems 510(k')s",
May 3, 2004 is presented.
Comparisons of device performance data, materials, indications
and design/function to predicate devices, K063158 &K041167,
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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pioneer Surgical Technology % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, Michigan 49855
APR 2 8 2009
Re: K090222
Trade/Device Name: Pioneer Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: March 13, 2009 Received: March 16, 2009
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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- Mr. Jonathan M. Gilbert
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Mabel N. Malloy
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications: 2.0 Indications for Use Statement
Pioneer Lumbar Plate System
510(k) Number (if known): K090222
Device Name:
Indications:
The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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)
Mavare Richards A. MKM
Division Sign-Off
Division of General. Hestorative. and Neurological Devices
510(k) Number K090220