(330 days)
Not Found
No
The document describes a metallic implant for joint resurfacing and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hemi-arthroplasty implant intended to treat degenerative and post-traumatic arthritis, which are medical conditions, and aims to restore function to the MTP joint.
No
The device is an implant designed for treating degenerative and post-traumatic arthritis in the MTP joint, not for diagnosing conditions.
No
The device description clearly states it is a "one-piece device intended to resurface the base of the proximal phalanx" and is made of "cobalt chrome or titanium," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a "cannulated metallic hemi implant" intended to "resurface the base of the proximal phalanx" in the MTP joint. It is a physical implant used within the body during surgery.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
This device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.
The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.
The Vilex cannulated metallic hemi implant is intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to resurface the base of the proximal phalanx. It is similar in design to the predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of articular surface shape and fixation. Implants will be offered in cobalt chrome or titanium, with or without Hydroxyapatite (HA) coated stem and back as an option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsophalangeal (MTP) joint
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)
Based on the engineering analysis, the Vilex implants are equivalent to predicates in terms of mechanical integrity and resistance to bending torques.
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.
K023684, K041595, K911378, K084369, K081876, K971047
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.
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
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
0
510(k) Summary, K102401
| Sponsor: | Vilex in Tennessee, Inc., 111 Moffitt St., McMinnville, TN 37110,
931-474-7550 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sylvia Southard Date: July 8, 2011 |
| Device Name: | Cannulated Metallic Hemi Implant |
| Classification: | 21 CFR 888.3730 – Toe joint phalangeal (hemi-toe) polymer prosthesis, KWD |
| Predicate Devices: | K023684 Vilex Cannulated Metallic Hemi Implant
K041595 BioPro Hemi Joint with optional coating
K911378 Townley Great Toe Joint8: BioPro
K084369 Metasurg Hemi Joint
K081876 OsteoMed Resurfacing Metatarsal Implant with HA Coating
K971047 FUTURA Biomedical |
| Description of Device: | Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to
resurface the base of the proximal phalanx. It is similar in design to the
predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of
articular surface shape and fixation. Implants will be offered in cobalt chrome
or titanium, with or without Hydroxyapatite (HA) coated stem and back as an
option. |
| Material: | Cobalt chrome molybdenum alloy or Titanium Ti6Al4V (optional). The implant
may be cemented to the phalanx or press-fit without cement. |
| Indications for Use: | The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for
the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of
patients with degenerative and post-traumatic arthritis in the MTP joint in the
presence of good bone stock and integrity of the phalangeal base, along with
the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus,
and an unstable or painful MTP joint.
The Vilex cannulated metallic hemi implant is intended to be used with bone
cement or press fit without bone cement.
The Vilex cannulated metallic hemi implant is intended for single use only. |
| Non-Clinical Test Data | Based on the engineering analysis, the Vilex implants are equivalent to
predicates in terms of mechanical integrity and resistance to bending torques. |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Vilex Implants are
substantially equivalent to other legally marketed devices with and without HA
coating. The methods used to establish equivalence are comparisons of
indications for use, materials of construction, sizes, shapes, and mechanical
integrity analysis. |
| Establishment Reg. No.: | 1051526 |
1
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Vilex, Inc. % Ms. Sylvia Southard 111 Moffitt Street McMinnville, TN 37110
JUL 2 0 2011
Re: K102401
Trade/Device Name: Vilex Cannulated Metallic Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: July 8, 2011 Received: July 14, 2011
Dear Ms. Southard:
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 - Ms. Sylvia Southard
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,
Eunice Keith
Mark N. Melkerson 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: K102401
Device Name: Vilex Cannulated Metallic Hemi Implant
Indications for Use:
The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.
The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.
The Vilex cannulated metallic hemi implant is intended for single use only.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for N. Melkerson
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102401