(118 days)
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is intended to provide immobilization and stabilization of various spinal segments for conditions like severe spondylolisthesis, fracture, and scoliosis, which are therapeutic interventions.
No
The device is a spinal fixation system, which is a surgical implant designed to provide immobilization and stabilization of spinal segments, not to diagnose medical conditions.
No
The device description explicitly states it consists of physical components like rods, screws, hooks, and connectors, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the flamenco™ is a spinal fixation system used to immobilize and stabilize spinal segments as an adjunct to fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like rods, screws, and hooks, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. The flamenco™ is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.
When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
Product codes
MNI, MNH, KWP
Device Description
The flamenco™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spinal segments; L5-S1 vertebra; non-cervical posterior spine (T1 to S2)
Indicated Patient Age Range
skeletally mature patients
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 and torsion, and dynamic compression bending of the worst case flamenco™ construct was performed according to ASTM F1717. The mechanical test results demonstrated that flamenco™ performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031655, K041460, K992168, K022623, K950099, K974749, K024096, K031585, K051971, K100377
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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Image /page/0/Picture/2 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is written in a bold, sans-serif font, with the "U" in white against a black square. Below the word "Ulrich" is the text "medical USA", written in a smaller, sans-serif font.
510(k) Summary
| Date: | 24 January 2011 |
|---|---|
| Sponsor: | ulrich GmbH & Co. KG |
| Buchbrunnenweg 12 | |
| 89081 Ulm | |
| Germany | |
| Phone: +49 (0) 731-9654-1304 | |
| Fax: +49 (0) 731-9654-2802 | |
| Contact Person: | Hans Stover |
| ulrich medical USA, Inc. | |
| 754 Spirit 40 Park Drive | |
| Chesterfield, MO 63005 | |
| Phone: (636) 519-0268 | |
| Proposed Trade Name: | flamenco™ spinal fixation system |
| Device Classification | Class II |
| Classification Name: | Pedicle screw spinal system & Spinal interlaminal fixation orthosis |
| Regulation: | 888.3070 & 888.3050 |
| Device Product Code: | MNI/MNH & KWP |
| Device Description: | The flamenco™ consists of rods, monoaxial and polyaxial pedicle |
| screws, hooks and transverse connectors with locking set screws. | |
| The components are available in various sizes to accommodate | |
| differing patient anatomy. Rods are available in one diameter and | |
| a variety of lengths. Monoaxial and polyaxial screws are available | |
| in a variety of diameter-length combinations. Hooks are offered in | |
| a variety shapes and sizes. | |
| Intended Use: | The flamenco™ is a spinal fixation system intended to provide |
| immobilization and stabilization of thoracic, lumbar, and sacral | |
| spinal segments as an adjunct to fusion. | |
| When used as posterior, pedicle screw fixation, the system is | |
| intended for the treatment of severe spondylolisthesis (grades 3 | |
| and 4) of the L5-S1 vertebra in skeletally mature patients. In | |
| addition, when used as a pedicle screw fixation system in the non- | |
| cervical posterior spine (T1 to S2), the system is intended for the | |
| treatment of the following acute and chronic instabilities or | |
| deformities: degenerative spondylolisthesis with objective | |
| evidence of neurologic impairment, fracture, dislocation, spinal | |
| stenosis, scoliosis, kyphosis, lordosis, spinal tumor, | |
| pseudarthrosis and failed previous fusion in skeletally mature | |
| patients. | |
| When used as a posterior, non-cervical, hook and/or sacral/iliac | |
| fixation system (i.e., non-pedicle screw), the flamenco™ is | |
| intended for the treatment of the following acute and chronic | |
| instabilities or deformities: degenerative disc disease (as |
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KI02853
page 2 of 2
conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion. Materials: The flamenco™ components are manufactured from titanium alloy (Ti-6Al-4V) as described by ISO 5832-3 / ASTM F136. Predicate Devices: CD HORIZON® (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima™ (K024096/K031585/K051971) Diamondback™ (K100377) Technological The flamenco™ possesses the same technological characteristics Characteristics: as the predicate devices. These include • basic design (rod-based fixation system having monoaxial and polyaxial pedicle screws and various hook shapes and sizes), material (titanium alloy), . · sizes (rod and screw sizes are encompassed by those offered by the predicate systems) and intended use (as described above). . The fundamental scientific technology of the flamenco™ is the same as previously cleared devices. Performance Data: Static compression bending and torsion,
and dynamic compression bending of the worst case flamenco™ construct was performed according to ASTM F1717. The mechanical test results demonstrated that flamenco™ performs as well as or better than the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring. MD 20993-0002
JAN 2 5 2011
ulrich GmbH & Co. KG % ulrich medical USA, Inc. Mr. Hans Stover 754 Spirit 40 Park Drive Chesterfield, Missouri 63005
Re: K102853
Trade/Device Name: flamenco™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: December 09, 2010 Received: December 10, 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 misleading.
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
3
Page 2 - Mr. Hans Stover
or any Federal statutes and regulations administered by other Federal agencies. You must 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/McdicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
for
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K102853
Device Name: flamenco™ spinal fixation system
Indications for Use:
The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.
When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, 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)
(Division Sign
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K102853