BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW

K013558 · Blackstone Medical, Inc. · KWQ · Jan 23, 2002 · Orthopedic

Device Facts

• Record ID: K013558
• Device Name: BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
• Applicant: Blackstone Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients: a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass. The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: a) Degenerative spondylolisthesis with objective evidence of neurologic impairment: b) Fracture; c) Dislocation: d) Scoliosis; e) Kyphosis; f) Spinal tumor: and g) Failed previous fusion (pseudarthrosis). The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis: c) Spondylolisthesis; d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); e) Pseudarthrosis; f) Tumor: g) Trauma (i.e., fracture or dislocation); h) Previous failed fusion.

Device Story

Titanium alloy spinal fixation system; includes 4.5mm mono-axial screws and rods; used by surgeons to build spinal implant constructs; provides immobilization and stabilization of spinal segments as adjunct to fusion; non-sterile, single-use components; attached to vertebral body via screws; fully interchangeable with existing Blackstone Spinal Fixation System components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy; mono-axial screw design; 4.5mm diameter; non-sterile; single-use; mechanical spinal fixation; compatible with existing Blackstone Spinal Fixation System components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine instabilities/deformities including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, spinal stenosis, and degenerative disc disease. Specific pedicle screw use restricted to severe spondylolisthesis (Grades 3-4) at L5-S1 with autogenous bone graft.

Regulatory Classification

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.

Predicate Devices

• DePuy Motech Moss Miami Spinal System (K980477, K982320)

Submission Summary (Full Text)

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### JAN 2 3 2002

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Alan Lombardo<br>Director of Engineering |
| Trade Name: | Blackstone™ Spinal Fixation System<br>4.5mm Mono-Axial Screw (System Addition) |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code<br>& Classification: | MNH 888.3070 - Spondylolisthesis Spinal<br>Fixation Device System<br>KWQ 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis<br>MNI 888.3070 - Pedicle Screw Spinal System |
| Substantially<br>Equivalent Devices: | DePuy Motech Moss Miami Spinal System (K980477,<br>K982320). |

#### Device Description:

The Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screw is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The Blackstone™ Spinal Fixation System consists of an assortment of screws and rods which have received 510k clearance (K994217 & K003735). The 4.5mm Mono-Axial Screws are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217 & K003735).

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#### Intended Use / Indications for Use:

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and
- d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

- a) Degenerative spondylolisthesis with objective evidence of neurologic impairment:
- b) Fracture;
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis;
- f) Spinal tumor: and
- g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis:
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- e) Pseudarthrosis;
- f) Tumor:
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

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### BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ 4.5mm Mono-Axial Screw by its very nature is substantially equivalent to the DePuy Motech Moss Miami Spinal System (K980477, K982320) which has been cleared by FDA for certain anterior and pedicle fixation use indications.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an inner symbol. The inner symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 3 2002

Mr. Alan Lombardo Director of Engineering Blackstone Medical Incorporated 90 Brookdale Drive Springfield, MA 01104

Re: K013558

> Trade Name: Blackstone™ Spinal Fixation System - 4.5 mm Mono Axial Screws Regulation Number: 21 CFR 888.3060 and 888.3070 Regulation Name: Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System, Pedicle Screw Spinal System Regulatory Class: II Product Code: KWO, MNH, MNI Dated: October 24, 2001 Received: October 25, 2001

Dear Mr. Lombardo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Alan Lombardo

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Millhusan

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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K OI રૂ ર ( 1 ex 2 ) 510(k) Number:

Device Name: Blackstone™ Spinal Fixation System

#### Indications for Use:

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

- a) Degenerative spondylolisthesis with objective evidence of neurologic impairment
- b) Fracture;
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis:
- Spinal tumor; and f)
- g) Failed previous fusion (pseudarthrosis).

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

510(k) Number _

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle
fixation, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis;

Summary

KO13558

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K013558
(2042)

- Spondylolisthesis; c)
- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- e) Pseudarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

Concurrence of CDRH, Office of device Evaluation

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR801.109

for Mark N. McMillen

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

510(k) Number _