(59 days)
Not Found
No
The summary describes a physical implant (cervical cage) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "TRYPTIK® cages" which are "used to facilitate intervertebral body fusion in the cervical spine" for patients with degenerative disc disease. This indicates a direct therapeutic action to treat a medical condition.
No
The device, TRYPTIK® cages, is an implant used to facilitate intervertebral body fusion, not to diagnose a condition. Its indication for use is in patients already diagnosed with degenerative disc disease.
No
The device description explicitly states the components are made of PEEK and titanium, which are physical materials, not software. The device is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TRYPTIK® cage is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not in vitro (in a lab setting).
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a diagnostic test performed on a sample.
- Device Description: The description details the materials and design of a physical implant.
- Performance Studies: The performance studies focus on mechanical testing of the implant's structural integrity, not on the accuracy or reliability of a diagnostic test.
Therefore, the TRYPTIK® cage falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
TRYPTIK® cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment.
Product codes
ODP
Device Description
The components added within this submission include lordotic and convex TRYPTIK® cc anterior intersomatic cervical cages. TRYPTIK® devices are made of PEEK OPTIMA LT1 conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. TRYPTIK® devices are designed for an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at the C3 to C7 disc levels
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
Mechanical testing including Static and dynamic compression, static and dynamic shear, static and dynamic torsion tests have been performed according to ASTM F2077 and subsidence testing has been performed according to ASTM F2267. Results demonstrate that additional components perform as safely and effectively as their predicate devices. No clinical data has been presented.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K122366
page 1 of.1
510(k) SUMMARY
As required by section 807.92
ост 4 2012
| Submitter | SPINEART
International Center Cointrin 20 route de pré-bois CP1813
1215 GENEVA 15
SWITZERLAND |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality
Phone : +41 22 799 40 25 Fax : +41 22 799 40 26
Mail : fpennesi@spineart.ch
Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)
idrubaix@nordnet.fr |
| Type of 510k | SPECIAL |
| Preparation date | Revised September 9th 2012 |
| Trade Name | TRYPTIK® Anterior Intersomatic Cervical Cage |
| Classification Name | Intervertebral body fusion device- Cervical |
| Class | II |
| Product Code | ODP |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketed
predicate devices | TRYPTIK® Anterior Intersomatic Cervical Cage manufactured by
SPINEART (K091873); CRYSTAL manufactured by SPINAL ELEMENTS,
INC (K073351); ALEUTIAN manufactured by K2M (K101302) |
| Description | The components added within this submission include lordotic and
convex TRYPTIK® cc anterior intersomatic cervical cages. TRYPTIK®
devices are made of PEEK OPTIMA LT1 conforming ASTM F2026.
Markers made of titanium conforming ASTM F136 are used to visualize
the position of the implant in the disc space. TRYPTIK® devices are
designed for an anterior approach. |
| Intended Use | TRYPTIK® cages are indicated for use in skeletally mature patients with
degenerative disc disease (DDD) of the cervical spine with
accompanying radicular symptoms at one disc level. DDD is defined as
discogenic pain with degeneration of the disc confirmed by patient
history and radiographic studies. TRYPTIK® cages are used to facilitate
intervertebral body fusion in the cervical spine at the C3 to C7 disc
levels using autograft bone. TRYPTIK® cages are to be used with
supplemental fixation. Patients should have at least six (6) weeks of
non-operative treatment. |
| Performance data | TRYPTIK® cervical interbody fusion devices conform to Class II Special
Controls Guidance Document: Intervertebral Body Fusion Device-
Document issued on: June 12, 2007.
Mechanical testing including Static and dynamic compression, static
and dynamic shear, static and dynamic torsion tests have been
performed according to ASTM F2077 and subsidence testing has been
performed according to ASTM F2267. Results demonstrate that
additional components perform as safely and effectively as their
predicate devices. No clinical data has been presented. |
| Substantial equivalence | TRYPTIK® cervical interbody fusion devices are substantially equivalent
to their predicate devices in terms of intended use, material, design,
mechanical properties and function. Non clinical performance testing
according to special control demonstrate that additional components
are as safe, as effective, and performs as safely and effectively as their
predicate devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SPINEART % Mr. Frank Pennesi Director of Industry and Quality International Center Cointrin, 20 route de-Pré-bois CP1813 1215 Geneva, Switzerland
OCT
4 2012
Re: K122366 Trade/Device Name: TRYPTIK® Anterior Intersomatic Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 10, 2012 Received: September 11, 2012
Dear Mr. Pennesi:
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 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
2
Page 2 - Mr. Frank Pennesi
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Mark N. Me Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): K122366
Device Name: TRYPTIK® Anterior Intersomatic Cervical Cage Indications for Use:
TRYPTIK® cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment
Prescription Use >| (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cal. Pf.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122366