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 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.

AI/ML Overview

This document is a 510(k) summary for a medical device called mambo™, an Anterior Cervical System. It is focused on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a clinical study. Therefore, much of the requested information (like multi-reader multi-case studies, ground truth establishment, training set details, and specific performance metrics beyond mechanical testing) is not typically part of a 510(k) submission and is not present in this document.

Here's an analysis of the provided information relative to your request:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical performance according to ASTM F1717 for static compression bending, tension bending, torsion, and dynamic compression bending.	The mechanical test results demonstrated that mambo™ performs as well as or better than the predicate devices (Spider Cervical Plating System, K052292; CLSP, K945700; ABC2 Anterior Cervical Plating System, K974706 and K0000486).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: This document describes mechanical testing according to ASTM F1717, not a human clinical trial or a test set involving patient data. The sample sizes for the mechanical tests (e.g., number of constructs tested) are not explicitly stated.
Data Provenance: Not applicable as this is mechanical testing, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This document pertains to mechanical testing of a physical implant, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is mechanical testing, not a study requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC comparative effectiveness study is not mentioned as this device is a physical implant (anterior cervical system), not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The mambo™ is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth: For mechanical testing, the "ground truth" is typically defined by the material properties, design specifications, and the established standards (ASTM F1717 in this case) that dictate acceptable performance ranges. The performance of the predicate devices serves as a benchmark for "as well as or better than."

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI system that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is a physical medical device.

Summary

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K0908G1

510(k) Summary

Date Prepared: 21 May 2010

MAY 2 1 2010

Submitter Information

Company Name and Address:	Contact Name:
ulrich GmbH & Co. KGBuchbrunnenweg 1289081 UlmGermany	Hans Stover, President and CEOulrich medical USA754 Spirit 40 Park Dr.St. Louis, MO 63005 USAPhone: 636-519-0268

Name of Device

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

Classification Name and Reference per Title 21 Code ofFederal 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

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609086

Intended Use and Indications for Use

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.

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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

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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 (800) 638-2041 or (301) 796-7100 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

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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

Regulation Number and Section

N/A