(24 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a spinal fixation system intended as an adjunct to fusion for a variety of spinal conditions, which corrects anatomical issues rather than directly treating a disease or condition therapeutically.
No
The device is described as a spinal fixation device, intended for use as an adjunct to fusion for various spinal conditions, not for diagnosing them.
No
The device description explicitly states it is a "Spinal Rod System components" and mentions "implants and instruments," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a spinal fixation system used as an adjunct to fusion for various spinal conditions. This is a surgical implant used in vivo (within the body) to provide structural support and stability.
- Device Description: The description reinforces that it's a system of implants and instruments for spinal fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Pioneer LowTop Spinal Rod System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pioneer LowTop Spinal Rod System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.
Product codes
NKB, KWP, KWQ, MNH, MNI
Device Description
LowTop Spinal Rod System components are Class III, as per the Code of Federal Regulations, Title 21, Section 888.3050, 888.3060 and 888.3070: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System, and Pedicle Screw Spinal System. The product codes are NKB, KWP, KWQ, MNH, and MNI. The Panel code is 87.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, T1 - S2, T8 - 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
Testing per recognized ASTM standards was presented.
Key Metrics
Not Found
Predicate Device(s)
K072187, K070933, K070973, K070551, K041167
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
| 3.0 | 510(k) Summary | |
|---|---|---|
| Sponsor: | Pioneer Surgical Technology | |
| 375 River Park Circle | ||
| Marquette, MI 49855 | ||
| (906) 226-4812 | ||
| Contact: Jonathan M. Gilbert | ||
| MAR 20 2008 | ||
| Device Name: | LowTop Spinal Rod System | |
| Classification | ||
| Name: | LowTop Spinal Rod System components are Class III, as per | |
| the Code of Federal Regulations, Title 21, Section 888.3050, | ||
| 888.3060 and 888.3070: Spinal Interlaminal Fixation Orthosis, | ||
| Spinal Intervertebral Body Fixation Orthosis, | ||
| Spondylolisthesis Spinal Fixation Device System, and | ||
| Pedicle Screw Spinal System. The product codes are NKB, | ||
| KWP, KWQ, MNH, and MNI. The Panel code is 87. | ||
| Predicate Device: | K072187 - Pioneer LowTop Spinal Rod System (SE Date 10/12/07) | |
| K070933 - Sanacor LowTop Pedicle Screw System (SE Date 6/13/07) | ||
| K070973 - Quantum Spinal System (SE Date July 3, 2007) | ||
| K070551 - Quantum Spinal System (SE date - March 29, 2007) | ||
| K041167 - Quantum Spinal System (SE date - July 23, 2004) | ||
| Intended Use: | The Pioneer LowTop Spinal Rod System components are | |
| non-cervical spinal fixation devices intended for use as an | ||
| adjunct to fusion as a pedicle screw system (T1 - S2), a | ||
| posterior hook and sacral/iliac screw fixation system or as an | ||
| anterolateral fixation system (T8 - L5). Pedicle screw fixation | ||
| is limited to skeletally mature patients. These devices are | ||
| indicated for all of the following indications regardless of the | ||
| intended use: degenerative disc disease (defined as | ||
| discogenic back pain with degeneration of the disc | ||
| confirmed by history and radiographic studies), | ||
| spondylolisthesis, trauma, (i.e., fracture or dislocation), | ||
| deformities or curvatures (i.e., scoliosis, kyphosis, and/or | ||
| lordosis, Scheuermann's Disease), tumor, stenosis, | ||
| pseudoarthosis, and failed previous fusion. | ||
| Material: | Materials 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: | The LowTop Spinal Rod System implants are substantially | |
| equivalent to the components of a previously cleared | ||
| Pioneer spinal system, with similar materials, | ||
| performance, and indications for use demonstrated. |
1
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 three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pioneer Surgical Technology % Mr. Jonathan M. Gilbert VP of Clinical & Regulatory Affairs 375 River Park Circle Marquette, MI 49855
MAR 2 0 2008
Re: K080504
Trade/Device Name: LowTop Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: February 22, 2008 Received: February 25, 2008
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
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
| 510(k) Number (if known): | K080504 |
|---|---|
| Device Name: | Pioneer LowTop Spinal Rod System |
| Indications for Use: | The Pioneer LowTop Spinal Rod System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion. |
Prescription Use OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonitu
(Division Sign-Off)
for Division of General, Restorative,
and Neurological Devices
510(k) Number K080504