(417 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant system for spinal stabilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an implant system for the anterior operative stabilization of the cervical spine, indicated for conditions like degenerative disc disease, trauma, and spinal stenosis, with the goal of temporary stabilization during the development of fusion. These are all therapeutic applications.
No
The device is described as a modular implant system for stabilizing the cervical spine, not for diagnosing conditions. Its intended use involves temporary stabilization during fusion and treatment of various spinal conditions, none of which involve diagnostic capabilities.
No
The device description clearly states that mambo™ is a modular implant system consisting of plates and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- mambo™ Function: The description clearly states that mambo™ is a "modular implant system for the anterior operative stabilization of the cervical spine." It is a physical device implanted into the body to provide structural support.
- Intended Use: The intended use describes surgical stabilization of the spine, not the analysis of biological samples.
Therefore, mambo™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052292, K945700, K974706, K0000486
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.
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 | |
| Buchbrunnenweg 12 | |
| 89081 Ulm | |
| Germany | Hans Stover, President and CEO |
| ulrich medical USA | |
| 754 Spirit 40 Park Dr. | |
| St. Louis, MO 63005 USA | |
| Phone: 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 of
| 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
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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 (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
4
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
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