(80 days)
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) 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.
Quantum Spinal System
This document is a 510(k) premarket notification for the Pioneer Quantum Spinal System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.
Therefore, I cannot provide the requested information. The document explicitly states:
"Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence."
This indicates that the submission relied on comparing the new device to existing, legally marketed devices rather than presenting novel performance studies against predefined acceptance criteria for the Quantum Spinal System itself.
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JUL 2 3 2004
Summary of Safety and Effectiveness Information 3.0
| SPONSOR: | PIONEER SURGICAL TECHNOLOGY375 River Park CircleMarquette, MI 49855(906) 226-4812Contact: Jonathan M. Gilbert |
|---|---|
| DEVICE NAME: | Quantum Spinal System |
| CLASSIFICATIONNAME: | Spinal Interlaminal Fixation Orthosis, SpinalIntervertebral Body Fixation Orthosis,Spondylolisthesis Spinal Fixation Device Systemand Pedicle Screw Spinal System, Class II. |
| INTENDED USE: | The Quantum Spinal System components arenon-cervical spinal fixation devices intended foruse as a posterior pedicle screw system (T1 - S2)or as an anterolateral fixation system (T8 - L5).Pedicle screw fixation is limited to skeletallymature patients. These devices are indicated forall of the following indications regardless of theintended use: degenerative disc disease (definedas discogenic back pain with degeneration of thedisc confirmed by history and radiographicstudies), spondylolisthesis, trauma, (i.e., fractureor dislocation), deformities or curvatures (i.e.,scoliosis, kyphosis, and/or lordosis,Scheuermann's Disease), tumor, stenosis,pseudoarthosis, and failed previous fusion. |
| Performance and SEDetermination: | Comparisons of device performance data,materials, indications and design/function topredicate devices were provided in making adetermination of substantial equivalence* |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Mr. Jonathan M. Gilbert Director, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855
K041167 Re:
Trade Name: Pioneer Quantum Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, KWP, MNH and MNI Dated: April 30 and July 1, 2004 Received: May 4 and July 6, 2004
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.
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Page 2 - Mr. Jonathan M. Gilbert
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i hat FDA has made a determination that your device complies with other requirements of the Act that I 127 has made a cond regulations administered by other Federal agencies. You must or uny I edolul bakator and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set el R Furt 607); adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quant on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product railled would begin marketing your device as described in your Section 510(k) I mis letter will and in your le FDA finding of substantial equivalence of your device to a legally premated 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.0
Indications For Use Statement
Page 1 of 1
K041167 510(k) Number (if known):
Quantum Spinal System Device Name:
Indications:
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✗ OR Over-the-Counter Use __
(Per 21 CFR 801.109)
for Mack n Meller
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Numb__ K04 116.7
N/A