(90 days)
Not Found
No
The device description and intended use focus solely on the mechanical components and surgical application of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a variety of spinal conditions, which is a therapeutic purpose.
No
The device is a system for immobilizing and stabilizing spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description clearly states the system consists of physical components like rods, screws, and crosslinks made of titanium alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the uCentum™ system is for "immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details physical components like rods, screws, and crosslinks made of titanium alloy, which are typical of surgical implants.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens.
The uCentum™ comprehensive posterior system is a surgical implant used in spinal fusion procedures.
N/A
Intended Use / Indications for Use
The uCentum™ comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.
Product codes
MNI, MNH, NKB
Device Description
The uCentum™ comprehensive posterior system consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available straight and curved in a variety of lengths. Polyaxial screws are available in a variety of diameterlength combinations. Crosslinks are offered in five lengths. The system can be implanted in open or minimally invasive procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine (T1-S2)
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)
Mechanical testing of the worst case uCentum ™ constructs included static and dynamic compression bending, and static torsion according to ASTM F1717. The mechanical test results demonstrated that uCentum™ performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052385, K120891, K102853, K992168, K022623, K110280
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
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.
(b)
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.
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page 1 of 2
MAR 0 4 2013
Image /page/0/Picture/3 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" being larger than the other letters. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
Date: Sponsor:
| 28 November 2012 | |
|---|---|
| ulrich GmbH & Co. KG | |
| Buchbrunnenweg 12 | |
| 89081 Ulm | |
| Germany | |
| Phone: | +49 (0) 731-9654-1304 |
| Fax: | +49 (0) 731-9654-2802 |
| Hans Stover |
Contact Person:
ulrich medical USA, Inc. 612 Trade Center Blvd. Chesterfield, MO 63005 (636) 519-0268 Office (636) 519-0271 Fax
Contact Person:
Proposed Trade Name: Device Classification Classification Name:
Regulation: Device Product
Code:
Class II and Class III
Pedicle screw spinal system
uCentum™ comprehensive posterior system
888.3070
MNI, MNH, NKB
Submission Purpose:
Submission Purpose: This submission adds modified components (screw, rod and crosslink options).
Device Description:
Intended Use:
The uCentum™ comprehensive posterior system consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available straight and curved in a variety of lengths. Polyaxial screws are available in a variety of diameterlength combinations. Crosslinks are offered in five lengths. The system can be implanted in open or minimally invasive procedures .
The uCentum™ comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.
1
K123717
:
and the comments of the comments of the comments of the contraction of the consisted on
and the comments of the comments of
| Materials: | The uCentum™ system components are manufactured from titanium
alloy (Ti-6Al-4V ELI) as described by ASTM F136. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices: | tangoRS™ (K052385 and K120891)
flamenco™ (K102853)
Moss Miami (K992168/K022623)
Revlock™ Fenestrated Screw System (K110280) |
| Performance Data: | Mechanical testing of the worst case uCentum ™ constructs included
static and dynamic compression bending, and static torsion
according to ASTM F1717.
The mechanical test results demonstrated that uCentum™
performance is substantially equivalent to the predicate devices. |
| Technological
Characteristics: | The uCentum™ comprehensive posterior system possesses the
same technological characteristics as one or more of the predicate
devices. These include:
• performance (as described above),
• basic design (rod-based, having screw anchors),
• material (titanium alloy) and
• sizes (dimensions are comparable to those offered by the
predicate systems).
Therefore the fundamental scientific technology of the uCentum™
comprehensive posterior system is the same as previously cleared
devices. |
| Conclusion: | The uCentum™ comprehensive posterior system possesses the
same intended use and technological characteristics as the predicate
devices. Therefore the uCentum™ comprehensive posterior system
is substantially equivalent for its intended use. |
and the comments of the comments of the comments of the comments of
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2013
ulrich GmbH & Company KG % ulrich medical USA, Incorporated Mr. Hans Stover 612 Trade Center Boulevard Chesterfield, Missouri 63005
Re: K123717
Trade/Device Name: uCentum™ comprehensive posterior system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: November 28, 2012 Received: December 4, 2012
Dear Mr. Stover:
We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave a sove 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 for ass sured in the 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 and Cosmetto her (rect). Tot ). " on imigations described below. The general controls provisions of the provisions of the riot and the mixed registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling:
"The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye."
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
3
Page 2 - Mr. Hans Stover
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the de rice results in a classinoon you to begin marketing your device as described in your Section 5 I0(k) premarket notification if the limitation statement described above is added to your labeling.
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 or any I vith 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 note the regulation of 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 yours,
Christy L. Foreman
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K123717
Device Name: uCentum™ comprehensive posterior system
Indications for Use:
The uCentum™ comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.
Prescription Use X (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)
Ronald®: Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123717