(20 days)
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The intended use states it is designed to supplement joint arthroplasty for conditions like hallux limitus/rigidus and painful arthritis, which are therapeutic interventions.
No
The device, the Metal Hemi Implant, is a prosthesis designed to supplement joint arthroplasty, which is a treatment or surgical intervention, not a diagnostic procedure.
No
The device description clearly states it is a "Metal Hemi Implant," which is a physical prosthesis, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Metal Hemi Implant is a surgical implant designed to be placed within the body to supplement a joint. It is a physical prosthesis, not a tool for analyzing biological samples.
The device is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The Metal Hemi Implant requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
Materials:
The substrate of the Metal Hemi Implant is fabricated from CoCrMo alloy per ASTM F75 Plasma spray of commercially pure titanium per ASTM F67 is placed on the inferior surface and base of the stem of the implant
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first proximal phalanx, first metatarsal phalangeal 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)
Not Found
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.
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 for the Metal Hemi Implant
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Metal Hemi Implant.
MAY 23 2007
Date Prepared: May 1, 2007
-
- Submitter: OrthoPro LLC 3450 Highland Dr. #303 Salt Lake City, UT 84106
Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
- Submitter: OrthoPro LLC 3450 Highland Dr. #303 Salt Lake City, UT 84106
-
- Trade name: Common Name: Classification Name:
Metal Hemi Implant Hemi toe prosthesis, toe, hemi-, phalangeal Class II per 21 CFR section 888.3730 KWD
- Trade name: Common Name: Classification Name:
-
- Predicate or legally marketed devices which are substantially equivalent: OrthoPro Hemi toe (K062908) was modified resulting in the Metal Hemi Implant.
-
- Description of the device:
The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The Metal Hemi Implant requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
Materials:
The substrate of the Metal Hemi Implant is fabricated from CoCrMo alloy per ASTM F75 Plasma spray of commercially pure titanium per ASTM F67 is placed on the inferior surface and base of the stem of the implant
5. Intended Use:
The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
Comparison of the technological characteristics of the device to predicate and legally marketed devices: 6.
The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OrthoPro LLC % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
AAY 2 3 2007
Re: K071243
Trade/Device Name: Metal Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: May 1, 2007 Received: May 3, 2007
Dear Mr. Webb:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 Mr. J.D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Pauline Brehm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): KOJ | 2 43
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Metal Hemi Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
Prescription Use X · (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nehare Buelu Df xox
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K071243