(11 days)
Not Found
No
The summary describes a physical implant device for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as "internal bone fixation" for bone fractures, fusions, or osteotomies, which are therapeutic interventions.
No
The document describes the device as being "intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot." This indicates its purpose is for treatment (fixation, repair) rather than diagnosis.
No
The device description explicitly states it is manufactured from PEEK-Optima® and consists of implants, which are physical hardware components.
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 device is for "internal bone fixation for bone fractures or osteotomies in the ankle and foot." This describes a surgical implant used directly within the body to stabilize bones.
- Device Description: The description details a "surgical implant" made from PEEK-Optima® with features for bone engagement. This aligns with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as:
Cotton and Evans Wedges
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform of Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
Midfoot Wedges - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine
TyPEEK System Indications
The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:
Cotton and Evans Wedges
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform of Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
Midfoot Wedges - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine
Product codes
PLF, HRS, HWC
Device Description
This submission is to add additional footprints to the system.
The Tyber Medical Wedge System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and indication configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle and foot
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)
• The worst-case device has not changed from the prior submission and so no new testing has been completed.
• Pyrogenicity testing was performed per ST72:2011.
Clinical data and conclusions were not needed for this device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tyber Medical LLC Mark F. Schenk Vice President of Regulatory and Ouality 83 S Commerce Way. Suite 310 Bethlehem. Pennsylvania 18017
May 16, 2017
Re: K171327
Trade/Device Name: Tyber Medical Wedge System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: PLF, HRS, HWC Dated: May 5, 2017 Received: May 5, 2017
Dear Mr. Schenk:
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 of medical device
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171327
Device Name Tyber Medical Wedge System
Indications for Use (Describe)
PEEK System Indications
The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as:
Cotton and Evans Wedges
- · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform of Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
- · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT os Lapidus)
The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine
TyPEEK System Indications
The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:
Cotton and Evans Wedges
- · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform of Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
- · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT of Lapidus)
The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
510(k) Summary of Safety and Effectiveness:
TYBER MEDICAL Wedge System
| Submitter by: | Tyber Medical LLC
83 South Commerce Way
Suite 310
Bethlehem, PA 18017 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mark F. Schenk
Vice President of Regulatory and Quality
Phone: (610) 849-0645 Fax: (866) 889-9914
Email: mschenk@tybermed.com |
| Date Prepared | May 12, 2017 |
| Common Names | Bone Wedge
Osteotomy Bone Wedge |
| Trade Name | Tyber Medical Wedge System |
| Classification Name
and Number | Single/multiple component metallic bone fixation appliances and accessories
(21 CFR 888.3030)
Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Product Code | PLF, HRS and HWC |
| Predicate Device | Tyber Medical Wedge System (K150394) |
| Device Description | This submission is to add additional footprints to the system.
The Tyber Medical Wedge System, manufactured from PEEK-Optima®, consist
of implants available in various foot prints, heights and indication
configurations with an open architecture to accept packing of bone graft
materials. The exterior of the device has "teeth" or other generally sharp
engagement members on the superior and inferior surfaces. The device
comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium
coating on the superior and inferior surfaces. |
4
Intended Use/ Indications for use
PEEK System Indications
The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as:
- Cotton and Evans Wedges
- Opening wedge osteotomies of the bones of the foot O including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform of Cotton osteotomies о
- Lateral Column Lengthening (Evans Lengthening Osteotomy o or Calcaneal Z Osteotomy)
- Midfoot Wedges
- O Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including o Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine
TyPEEK System Indications
The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:
- Cotton and Evans Wedges
- Opening wedge osteotomies of the bones of the foot o including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform of Cotton osteotomies O
- Lateral Column Lengthening (Evans Lengthening Osteotomy o or Calcaneal Z Osteotomy)
- Midfoot Wedges ●
- Opening wedge osteotomies of the bones of the foot o including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including o Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine
| Performance Data
(Non-Clinical) | • The worst-case device has not changed from the prior submission and sc
no new testing has been completed. |
| ------------------------------------ | ---------------------------------------------------------------------------------------------------------------- |
|---|
- · Pyrogenicity testing was performed per ST72:2011.
| Performance Data
| (Clinical) | Clinical data and conclusions were not needed for this device |
|---|---|
| -------------------------------- | --------------------------------------------------------------- |
5
| Statement of | Tyber Medical Wedge System and its predicate device have the same |
|---|---|
| Technological | indications for use, materials, technology and similar design, principles of |
| Comparison | operation and test results. |
| Conclusion | The new Tyber Medical Wedge System is substantially equivalent to the |
| predicate device because the material, tooth profile, heights, lengths and | |
| graft volume are unchanged. The addition of the new configurations does not | |
| add a new worst case device. Given that no new worst case is introduced, the | |
| new configurations to the Tyber Medical Wedge System do not raise any | |
| additional risk to safety and effectiveness. |