MAMBO, MODEL CS 18XX-XX

K090861 · Ulrich GmbH & Co. KG · KWQ · May 21, 2010 · Orthopedic

Device Facts

• Record ID: K090861
• Device Name: MAMBO, MODEL CS 18XX-XX
• Applicant: Ulrich GmbH & Co. KG
• Product Code: KWQ · Orthopedic
• Decision Date: May 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

mambo™ is intended for anterior operative stabilization of the cervical spine, (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies Spondylolisthesis Trauma (i.e., fracture or dislocation) Spinal stenosis Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

mambo™ is a modular anterior cervical spinal fixation system; consists of cranial, caudal, and extension plates; includes bone and revision screws. Surgeons use settling and clamping screws to configure the system as either a load-sharing (dynamic) or load-bearing (rigid) construct. Designed for anterior operative stabilization of cervical spine segments C2 to C7; accommodates one to five segments. Used by surgeons in clinical settings to provide temporary stabilization during spinal fusion procedures. Benefits patients by providing structural support to the anterior spine during the healing/fusion process. Device is purely mechanical; no software or electronic components.

Clinical Evidence

Bench testing only. Static compression bending, tension bending, torsion, and dynamic compression bending were performed according to ASTM F1717. Results demonstrated that the mambo™ construct performs as well as or better than the predicate devices.

Technological Characteristics

Modular anterior cervical plate system. Materials: Titanium or titanium alloy. Design: Plate-based screw system with settling/clamping screws for dynamic or rigid fixation. Dimensions: Plates 20-142 mm; screws 13-19 mm. Mechanical testing performed per ASTM F1717. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-C7) during spinal fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion. Contraindicated for posterior element (pedicle) fixation.

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

• Spider Cervical Plating System (K052292)
• CLSP (K945700)
• ABC2 Anterior Cervical Plating System (K974706, K0000486)

Submission Summary (Full Text)

{0}------------------------------------------------

# K0908G1

### 510(k) Summary

Date Prepared: 21 May 2010

## MAY 2 1 2010

#### Submitter Information

| Company Name and Address: | Contact Name: |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| ulrich GmbH & Co. KG<br>Buchbrunnenweg 12<br>89081 Ulm<br>Germany | Hans Stover, President and CEO<br>ulrich medical USA<br>754 Spirit 40 Park Dr.<br>St. Louis, MO 63005 USA<br>Phone: [phone] |

#### Name of Device

- Trade Name: mambo™M .
- Common Name: Anterior Cervical System .
- Classification Name and Reference: .

| Classification Name and Reference per Title 21 Code of<br>Federal Regulation (CFR) | Product Code |
|------------------------------------------------------------------------------------|-----------------|
| Part 888, Orthopedic Devices, Subpart D - Prosthetic Devices, | KWQ - Anterior |
| 888.3060, Spinal intervertebral body fixation orthosis | Cervical System |

#### Substantial Equivalence Claimed to Predicate Device

- Spider Cervical Plating System, K052292, X-Spine Systems .
- CLSP, K945700, Synthes (USA) .
- · ABC2 Anterior Cervical Plating System, K974706 and K0000486, Aesculap® Inc.

#### Device Description

mambo™ is a modular implant system for the anterior operative stabilization of the cervical spine (C2 to C7), only, consisting of cranial, caudal and extension plates as well as bone and revision screws of different sizes. Settling and clamping screws can be chosen for use of the mambo plate as a load-sharing (dynamic) or load-bearing (rigid) plate. The anterior cervical plates range in size from 20 mm to 142 mm to accommodate one to five segments of fixation. Bone and revision screws are available in lengths ranging from 13 mm to 19 mm.

{1}------------------------------------------------

# 609086

#### Intended Use and Indications for Use

mambo™ is intended for anterior operative stabilization of the cervical spine, (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- Degenerative disc disease (DDD), defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation) .
- Spinal stenosis .
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- . Tumor
- Pseudoarthrosis .
- Failed previous fusion

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

#### Technological Characteristics

mambo™ possesses the same technological characteristics as the predicate devices. These include basic design (plate-based screw system), material (titanium or titanium alloy), sizes (plate lengths and screw diameters and lengths are within the range(s) offered by the predicate systems) and intended use (as described above). The fundamental scientific technology of mambo™ is the same as previously cleared devices.

#### Performance Data

Static compression bending, tension bending and torsion, and dynamic compression bending of the worst case mambo™ construct was performed according to ASTM F1717. The mechanical test results demonstrated that mambo™ performs as well as or better than the predicate devices.

Pg 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head. The bird is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

Ulrich GmbH & Co. KG % Mr. Hans Stover President and CEO ulrich medical USA 754 Spirit 40 Park Dr. St. Louis, MO 63005

MAY 2 1 2010

Re: K090861

Trade/Device Name: mambo™M Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 23, 2010 Received: March 24, 2010

Dear Mr. Stover:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misJeading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

{3}------------------------------------------------

#### Page 2 -Mr. Hans Stover

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,
Oarkine Inums

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K090861

#### ODE Indications Statement 5.0

#### 510(k) Number (if known):

Device Name: mambo TM, Anterior Cervical System

#### Indications for Use:

mambo™ is intended for anterior operative stabilization of the cervical spine, C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- 피 Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- 트 Spondylolisthesis
- 트 Trauma (i.e., fracture or dislocation)
- Spinal stenosis
- I Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- 트 Tumor
- 에 Pseudoarthrosis
- 프 Failed previous fusion

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Prescription Use: X __ AND/OR Over-the-Counter Use: (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

**Conference of CDRH, Office of Device Evaluation (ODE)**

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KO40861 510(k) Number_

Traditional 510(k) - mambo™M 27 March 2009

Page 18 of 248