QUANTUM SPINAL SYSTEM

K070973 · Pioneer Surgical Technology · NKB · Jul 3, 2007 · Orthopedic

Device Facts

• Record ID: K070973
• Device Name: QUANTUM SPINAL SYSTEM
• Applicant: Pioneer Surgical Technology
• Product Code: NKB · Orthopedic
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1 - L5), sacral/iliac screw fixation 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.

Device Story

Quantum Spinal System is a non-cervical spinal fixation implant system. Components include pedicle screws, posterior hooks, and sacral/iliac screws. Used as an adjunct to spinal fusion. Implanted by surgeons in clinical settings to stabilize the spine. Provides mechanical support for patients with degenerative disc disease, deformities, trauma, or tumors. Titanium alloy implants are secured to the spine to facilitate fusion. Benefit is stabilization of the spinal column.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Implants manufactured from titanium alloy; instruments manufactured from medical grade stainless steel. Materials conform to ASTM standard specifications. System is a mechanical spinal fixation device consisting of screws, hooks, and rods. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical spinal fixation (T1-S2 pedicle, T1-L5 posterior hook, sacral/iliac, or T8-L5 anterolateral) for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), deformities (scoliosis, kyphosis, lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Quantum Spinal System (K041167)
• Quantum Spinal System (K070551)
• Synthes Pangea Monoaxial System (K052151)
• Synthes Click'X Monoaxial System (K031175)

Submission Summary (Full Text)

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| | Summary of Safety and Effectiveness Information |
|--|-------------------------------------------------|
|--|-------------------------------------------------|

K070973

| Sponsor: | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Jonathan M. Gilbert<br><br>JUL - 3 2007 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Quantum Spinal System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body<br>Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System<br>and Pedicle Screw Spinal System, Class III. |
| Predicate Device: | K041167 - Quantum Spinal System, K070551 - Quantum Spinal<br>System, K052151 - Synthes Pangea Monoaxial System, K031175 -<br>Synthes Click'X Monoaxial System |
| Intended Use: | The Quantum Spinal System components are non-cervical spinal<br>fixation devices intended as an adjunct to fusion for use as a pedicle<br>screw (T1-S2), posterior hook (T1 - L5), sacral/iliac screw fixation<br>or as an anterolateral fixation system (T8 - L5). Pedicle screw<br>fixation is limited to skeletally mature patients. These devices are<br>indicated for all of the following indications regardless of the<br>intended use: degenerative disc disease (defined as discogenic back<br>pain with degeneration of the disc confirmed by history and<br>radiographic studies), spondylolisthesis, trauma, (i.e., fracture or<br>dislocation), deformities or curvatures (i.e., scoliosis, kyphosis,<br>and/or lordosis, Scheuermann's Disease), tumor, stenosis,<br>pseudoarthosis, and failed previous fusion. |
| Material: | Materials used to manufacture the implants (titanium alloy) and<br>instruments (medical grade stainless steel) of this system are in<br>conformance with ASTM Standard Specifications. |
| Performance Data: | Testing per recognized ASTM standards was presented. |
| Performance and SE<br>Determination: | Comparisons of device performance data, materials, indications and<br>design/function to predicate devices were provided in making a<br>determination of substantial equivalence. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with flowing lines to suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pioneer Surgical Technology % Mr. Jonathan Gilbert VP, Clinical and Regulatory Affairs 375 River Park Circle Marquette, MI 49855

Re: K070973

Trade/Device Name: OUANTUM Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWQ, KWP, MNI, MNH Dated: April 4, 2007 Received: April 6, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

111 - 3 2007

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.

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Page 2 - Mr. Jonathan 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 Office of Compliance at [phone]. 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely, yours,
for

Mark N. Melkerson / 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

| 510(k) Number (if known): | K070973 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Quantum Spinal System |
| Indications for Use: | The Quantum Spinal System components are non-cervical spinal<br>fixation devices intended for use as a pedicle screw system (T1 - S2), a<br>posterior hook and sacral/iliac screw fixation system or as an<br>anterolateral fixation system (T8 - L5). Pedicle screw fixation is<br>limited to skeletally mature patients. These devices are indicated for all<br>of the following indications regardless of the intended use:<br>degenerative disc disease (defined as discogenic back pain with<br>degeneration of the disc confirmed by history and radiographic<br>studies), spondylolisthesis, trauma, (i.e., fracture or dislocation),<br>deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis,<br>Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed<br>previous fusion. |

Prescription Use
(Per 21 CFR 801.109) √

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

P.M.
(Division Sign-Off)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** k070973
Original 4/4/07
Revised 6/8/07

Pioneer Surgical Technology Premarket Notification