OSTEONICS SPINAL SYSTEM

K020293 · Howmedica Osteonics Corp. · MNH · Feb 14, 2002 · Orthopedic

Device Facts

• Record ID: K020293
• Device Name: OSTEONICS SPINAL SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MNH · Orthopedic
• Decision Date: Feb 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows: As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for: Long and short curve scoliosis . Vertebral fracture or dislocation . Spondylolisthesis . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies). Previously failed fusion . Spinal tumor . Pedicular Use: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

Device Story

Diapason Combo is a modified spinal fixation component for the Osteonics Spinal System; includes modified ring and blocker heights; enables use of Xia 6mm diameter rods with Osteonics system. Device is a single-use, non-sterile implant; intended for posterior spinal fixation. Operates as a mechanical fixation system; provides structural support to spine during fusion. Used by surgeons in clinical settings. Output is physical stabilization of vertebral segments; facilitates bone fusion. Benefits include correction of spinal deformities and stabilization of unstable spinal segments.

Clinical Evidence

Bench testing only. Static and fatigue testing performed to demonstrate mechanical equivalence of the modified Diapason Combo and the integration of Xia rods with the Osteonics Spinal System. No clinical data provided.

Technological Characteristics

Spinal fixation system components. Materials and dimensions modified from predicate. Mechanical fixation principle. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients with scoliosis, vertebral fracture/dislocation, spondylolisthesis, degenerative disc disease, failed fusion, or spinal tumor. Pedicular use indicated for skeletally mature patients with degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion, or severe spondylolisthesis (Grades 3-4) at L5-S1.

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

• Osteonics® Spinal System (OSS) Combination Screw Ring/Blocker (K990158)
• OSS Screw Blocker and Cap (K951725)
• Xia 6 mm diameter rods (K984251)

Submission Summary (Full Text)

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# FEB 1 4 2002

## Special 510(k): Device Modification for the Osteonics® Spinal System Summary of Safety and Effectiveness

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>59 Route 17<br>Allendale, NJ 07401-1677 |
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Contact Person:

Karen Ariemma Regulatory Affairs Specialist

Date of Summary Preparation:

January 25, 2002

#### Device Identification

Proprietary Name: Common Name: Classification Name and Reference:

Osteonics® Spinal System Spinal Fixation Appliances Spinal Interlaminal Fixation Orthosis 21 CFR 888.3050 Pedicle Screw Spinal System 21 CFR 888.3070

### Predicate Device Identification

The features of the subject device are substantially equivalent to features of the Osteonics® Spinal System (OSS) Combination Screw Ring/Blocker which was determined substantially equivalent via 510(k) K990158 and to the OSS Screw Blocker and Cap which were determined substantially equivalent via 510(k) K951725. The modified device shall be referred to here in as the Diapson Combo. The Xia 6 mm diameter rods were determined substantially equivalent via K984251.

### Description of Device Modification

The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.

#### Intended Use

The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows:

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20293 Plz

## As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

- Long and short curve scoliosis .
- Vertebral fracture or dislocation .
- Spondylolisthesis .
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
- Previously failed fusion
- Spinal tumor .

## Pedicular Use:

- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

## Statement of Technological Comparison:

Static and fatigue testing demonstrates the comparable mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap.

Static and fatigue testing demonstrates the acceptable mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with its head tilted upwards. The figure is composed of three overlapping profiles, creating a sense of depth and dimension. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2002

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401

Re: K020293

Trade Name: Osteonics® Spinal System Regulatory Number: 21 CFR 888.3070 and 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis, Regulatory Class: II Product Code: MNH, MNI, KWP Dated: January 25, 2002 Received: January 28, 2002

Dear Ms. Ariemma:

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 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocgin marketing your device to a legally marketed notification. The PDA inding of substantial equiveland 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 If you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in This allegitestions on the promotion and advertising of your device, [phone]. Rudinonary, 12. quese at [phone]. Also, please note the regulation prease contact the Office or Comphanes et notification" (21 CFR 807.97). Other general emined, "Misoranuming of relection to permanel from the Act may be obtained from the Division of Small information on your responsionnes and its not no nover [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

uriam 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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510(k) Number (if known): Kクスリ29 3

Device Name: Modification to the Osteonics® Spinal System

The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.

The uses for the legally marketed Osteonics® Spinal System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

- Long and short curve scoliosis
- Vertebral fracture or dislocation
- Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
- Previously failed fusion
- Spinal tumor

## Pedicular Use:

- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Miriam C. Provost

Over-The-Counter Use Division of General, Restorative Division of Golleral, Restorative Format 1-2-96)

K020293 510(k) Number_