BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR

K042100 · Blackstone Medical, Inc. · MNI · Sep 20, 2004 · Orthopedic

Device Facts

• Record ID: K042100
• Device Name: BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
• Applicant: Blackstone Medical, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone "M Ascent POCT System is indicated for: a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) b) spondylolisthesis c) spinal stenosis d) fracture/dislocation e) atlanto/axial fracture with instability occipitocervical dislocation f) g) revision of previous cervical spine surgery h) tumors The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The Songer Cable System to be used with the Blackstone™ POCT System allows for wire/cable attachment to the posterior cervical spine. The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector.

Device Story

The Blackstone™ Ascent POCT System is a titanium alloy spinal instrumentation system. The 5.5mm/3.0mm Single Axial Connector is a component modification allowing surgeons to connect rods of different diameters during spinal construct extension. The system is used by surgeons in clinical settings to build spinal implant constructs for posterior fixation. It provides mechanical stabilization to promote fusion. The device is non-sterile and single-use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy spinal instrumentation system; non-sterile, single-use components. Includes rods, set-screws, cross connectors, multi-axial screws, plates, bone screws, and cables. 5.5mm/3.0mm Single Axial Connector serves as a rod-to-rod connector.

Indications for Use

Indicated for patients requiring cervical spine or occipito-cervico-thoracic (occiput-T3) fusion due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision surgery, or tumors. Multi-axial screws limited to T1-T3 thoracic conditions; occipital screws limited to occipital fixation.

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

• Blackstone™ Ascent POCT System (K030197)

Reference Devices

• Blackstone Spinal Fixation System

Submission Summary (Full Text)

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Koy2100

Premarket Notification Special 510(k) SEP 2 0 2004 Blackstone Medical, Inc. Blackstone™ Ascent POCT System 5.5mm/3.0mm Single Axial Connector (System Modification)

K 042100

# 510(K) SUMMARY

| Name of Firm: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dean E. Ciporkin<br>Director, Regulatory Affairs and Quality Assurance |
| Trade Name: | Blackstone™ Ascent POCT System<br>5.5mm/3.0mm Single Axial Connector |
| Common Name: | Rod and Screw Spinal Instrumentation |
| Device Product Code<br>& Classification: | MNI - 888.3070 - Pedicle Screw Spinal System<br>KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis |

## Substantially Equivalent Devices:

Blackstone™ Ascent POCT System (K030197)

#### Device Description:

The Blackstone™ Ascent POCT System 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 Blackstone™ Ascent POCT System consists of an assortment of rods, set-screws, cross connectors, multi-axial screws, plates, bone screws and Songer Cables.

The 5.5mm/3.0mm Single Axial Connector addition will function as a rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to connect rods of different diameter when extending a construct.

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# 1.5 Intended Use / Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone "M Ascent POCT System is indicated for:

- a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- b) spondylolisthesis
- c) spinal stenosis
- d) fracture/dislocation
- e) atlanto/axial fracture with instability
- occipitocervical dislocation f)
- g) revision of previous cervical spine surgery
- h) tumors

The occipital bone screws are limited to occipital fixation only.

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ POCT System allows for wire/cable attachment to the posterior cervical spine.

The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

By its very nature, the Blackstone™ 5.5mm/3.0mm Single Axial Connector is substantially equivalent to the Blackstone™ Ascent POCT System (K030197), which has been cleared by FDA for posterior fixation applications to the occipito-cervical-thoracic junction.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

SEP 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K042100

K042100
Trade/Device Name: Blackstone™ Ascent POCT System 5.5mm/3.0mm Axial Connector Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, KWP Dated: August 2, 2004 Received: August 4, 2004

Dear Mr. Ciporkin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament of the device is substantially equivalent (for the indications ferenced above and harrsure) to legally marketed predicate devices marketed in interstate for ass black in to May 28, 1976, the enactment date of the Medical Device Amendments, or to oonimeres prior of risk as a reclassified in accordance with the provisions of the Federal Food, Drug, de rios mat have Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette Prove, 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 If your device is exassinon (tional controls. Existing major regulations affecting your device can may or days. It was a more 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 r reaso be actived that her mination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 OFF Fart 0077, accems (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. Dean E. Ciporkin

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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Blackstone™ Ascent POCT System 5.5mm/3.0mm Single Axial Connector

# Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Ascent POCT System is indicated for:

- a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- b) spondylolisthesis
- c) spinal stenosis
- d) fracture/dislocation
- e) atlanto/axial fracture with instability
- occipitocervical dislocation f)
- g) revision of previous cervical spine surgery
- h) tumors

The occipital bone screws are limited to occipital fixation only.

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ POCT System allows for wire/cable attachment to the posterior cervical spine.

The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the The Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector

Prescription Use X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
(Division Sign-Off)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division of General, Restorative, and Neurological Devices

**510(k) Number** k042100