(160 days)
No
The document describes a physical implant device for bone fixation and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes.
The device is used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, which is a therapeutic intervention.
No
The provided text describes the Tyber Medical PEEK Wedge System and TyPEEK Wedge System as implants for internal bone fixation for fractures, fusions, or osteotomies. It details their materials, design, and intended use as fixation devices, with no mention of diagnostic capabilities.
No
The device description clearly states it is a physical implant made from PEEK-Optima® with "teeth" or other engagement members, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a wedge system made of PEEK) intended for internal bone fixation in the ankle and foot. It is used within the body to stabilize fractures, fusions, or osteotomies.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition based on those samples. Its function is purely mechanical support and fixation.
Therefore, based on the provided information, the Tyber Medical PEEK and TyPEEK Wedge Systems are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
PEEK System Indications
The Tyber Medical PEEK 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
- o Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus o Opening wedge of Medial Cuneiform of Cotton osteotomies
- o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Midfoot Wedges
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o 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 TyPEEK 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
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o Opening wedge of Medial Cuneiform of Cotton osteotomies
- o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Midfoot Wedges
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o 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 (comma separated list FDA assigned to the subject device)
PLF, HRS, HWC
Device Description
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 come 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)
Non-clinical mechanical testing was performed consisting of Static Compression, Dynamic Compression, Static Compression-Shear, Static Torsion, Dynamic Torsion per ASTM F2077. Additionally, Expulsion testing was performed. The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978. All data indicates the device is substantial equivalence to the predicate systems.
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.
WRIGHT MEDICAL; Biofoam – K140531
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.
IBALANCE MEDICAL; AKR FX Medical Opening Wedge Tibial System – K092381, TYBER MEDICAL; Tyber Medical Interbody System – K130573, LIFE SPINE; Pro-Link Wedge System – K141905
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
July 28, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tyber Medical LLC Mr. Jeff Tyber CEO and President 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960
Re: K150394 Trade/Device Name: Tyber Medical Wedge System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: PLF, HRS, HWC Dated: June 19, 2015 Received: June 22, 2015
Dear Mr. Tyber:
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
1
Page 2 – Mr. Jeff Tyber
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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 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" (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 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 yours,
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) K150394
Device Name Tyber Medical Wedge System
Indications for Use (Describe) PEEK System Indications
The Tyber Medical PEEK 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
- o Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus o Opening wedge of Medial Cuneiform of Cotton osteotomies
- o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Midfoot Wedges
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o 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 TyPEEK 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
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o Opening wedge of Medial Cuneiform of Cotton osteotomies
- o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Midfoot Wedges
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o 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
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
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mark Schenk
Director of Quality and Regulatory
Phone: (610) 507-8255 Fax: (866) 889-9914
Email: mschenk@tybermed.com |
| Date Prepared | July 17, 2015 |
| 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 |
| Primary Predicates
Devices | 1. WRIGHT MEDICAL; Biofoam – K140531 |
| Reference Devices | 1. IBALANCE MEDICAL; AKR FX Medical Opening Wedge
Tibial System – K092381
2. TYBER MEDICAL; Tyber Medical Interbody System –
K130573
3. LIFE SPINE; Pro-Link Wedge System – K141905 |
| Device Description | 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 come
in a PEEK or PEEK with a plasma-sprayed commercially pure titanium
coating on the superior and inferior surfaces. |
| 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 |
| Performance Data
(Clinical) | Clinical data and conclusions were not needed for this device. |
| Statement of | The Tyber Medical Wedge System and its predicate devices have the same |
| Technological
Comparison | indications for use; same design; are made of similar materials, same application, and have the same anatomic mechanical properties. |
4
- Opening wedge osteotomies of the bones of the foot including O osteotomies for Hallux Valgus
- O Opening wedge of Medial Cuneiform of Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy O or Calcaneal Z Osteotomy)
- Midfoot Wedges ●
- Opening wedge osteotomies of the bones of the foot including O 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 including o 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 ●
- O Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- O 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
Performance Data Non-clinical mechanical testing was performed consisting of Static (Non-Clinical) Compression, Dynamic Compression, Static Compression-Shear, Static Torsion, Dynamic Torsion per ASTM F2077. Additionally, Expulsion testing was performed. The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978. All data indicates the device is substantial equivalence to the predicate svstems
5
| Conclusion | The Tyber Medical Wedge System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design test data and principles of operation. |
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