(225 days)
Not Found
Not Found
No
The summary describes a mechanical implant for joint replacement and does not mention any AI or ML components or functionalities.
Yes.
The device is indicated for joint replacement arthroplasty, which is a therapeutic intervention to treat conditions like rheumatoid arthritis and degenerative arthritis.
No
This device is an implant designed for joint replacement arthroplasty, not for diagnosing medical conditions.
No
The device description clearly states it is an "ulnar head implant," which is a physical medical device intended for surgical implantation.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The IsoelasticU™ is a surgical implant designed to replace the ulnar head in the wrist joint. It is a physical device used within the body during surgery.
- Intended Use: The intended use clearly states it's for "joint replacement arthroplasty of the ulnar head." This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a medical device used for treatment (joint replacement), not for diagnosing a condition using in vitro methods.
N/A
Intended Use / Indications for Use
The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications
- Rheumatoid arthritis with or without tendon ruptures
- Degenerative arthritis or post traumatic arthritis
- Arthrofibrosis of the DRUJ
- Reconstruction of the distal ulna post tumor resection
- Failed Ulnar Head Resection
- Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory changes
- Revision following failed ulnar head arthroplasty
Ulna stems are intended for uncemented use
Product codes (comma separated list FDA assigned to the subject device)
KXF
Device Description
The IsoelasticU ulnar head implant allows for replacement of the distal ulnar head much like the predicate metallic and silicone elastomer distal ulnar head implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radioulnar joint (DRUJ)
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.
SBI Uhead Implant, Silastic Swanson Ulnar Head Implant
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
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the acronym "REMI" in large, bold letters above the word "SCIENCES" in a smaller font. To the right of "REMI" are the words "REGENERATIVE ENGINEERED MATERIAL INNOVATIONS" in a very small font. The text appears to be a logo or heading.
510 k SUMMARY K081025
Date of preparation: 11/11/08
NOV 21 2008
Applicant: REMI SCIENCES INC 1400 Civic Place, Suite 225 Southlake, Texas76092
Telephone: (817) 506-0835 Fax: (817) 608-9403 Contact: Sanjiv H.Naidu
| DEVICE NAME: | Wrist joint ulnar (hemi-wrist) prosthesis |
|---|---|
| DEVICE TRADE NAME: | Isoclastic UTM |
| DEVICE CLASSIFICATION: | Class II |
| PREDICATE: | SBI Uhead Implant, Silastic Swanson Ulnar Head Implant |
DEVICE DESCRIPTION:
The IsoelasticU ulnar head implant allows for replacement of the distal ulnar head much like the predicate metallic and silicone elastomer distal ulnar head implants.
INDICATIONS FOR USE:
The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications
- Rheumatoid arthritis with or without tendon ruptures -
- Degenerative arthritis or post traumatic arthritis
- o 1. Arthrofibrosis of the DRUJ
-
- Reconstruction of the distal ulna post tumor resection ୍
-
- Failed Ulnar Head Resection
-
- Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory o changes
-
- Revision following failed ulnar head arthroplasty o
- Degenerative arthritis or post traumatic arthritis
Ulna stems are intended for uncemented use
REMI Sciences, Inc. 1400 Civic Place, Suite 225 Southlake, Texas 76092
ph 817-608-9400 ext.1600 fax 817-608-9403 cell 214-641-5171
sanj@remisciences.com www.remisciences.com
1
Image /page/1/Picture/1 description: The image shows the logo for REMI Sciences. The word "REMI" is in large, bold, black letters on the top left. To the right of "REMI" are the words "REGENERATIVE ENGINEERED MATERIALS INNOVATIONS" stacked on top of each other in smaller, gray letters. Below "REMI" are the words "SCIENCES" in gray letters.
Comparison to the Original Predicate Device:
IsoelasticU is substantially equivalent to the legally marketed SBI Small Bone Innovations U head implant.
Regulatory Class:II
| CATEGORY | REMI ISOELASTIC U | SBI UHEAD |
|---|---|---|
| Name | IsoelasticU | Uhead |
| Use | Single Use | Single Use |
| Fixation | Press fit stem | Press fit Stem |
| Material | UHMWPE/CpTitanium | Co-Cr/CpTi |
| Sizes | 19Head/9stems | 8head/4stem |
| Indications for use | - Rheumatoid arthritis with or without tendon ruptures |
- Degenerative arthritis or post traumatic arthritis
- Arthrofibrosis of the DRUJ
- Reconstruction of the distal ulna post tumor resection
- Failed Ulnar Head Resection
- Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory changes
- Revision following failed ulnar head arthroplasty | Is intended for replacement of the DRUJ following ulnar head resection arthroplasty: replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following: pain and weakness of the wrist joint not improved by conservative treatment instability of the ulnar head with xray evidence of dorsal subluxation and erosive changes and failed ular head resection |
Summary: Similarities of REMI Isoelastic U and SBI U head lies in the fact that they are both modular implants intended for use with press fit stems. Both the devices are intended for single use for implantation longer than 30 days. Both devices are made of standard industry materials with similar sizes and same indications.
REMI Sciences, Inc. 1400 Civic Place, Suite 225 Southlake, Texas 76092
. . . .
ph 817-608-9400 ext.1600 fax 817-608-9403 cell 214-641-5171
sanj@remisciences.com www.remisciences.com
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
REMI Sciences, Inc. % Sanjiv H. Naidu, M.D., Ph.D. Chief Medical Officer 1400 Civic Place. Suite 225 Southlake, Texas 76092
NOV 2 1 2008
Re: K081025
Trade/Device Name: Isoelastic UTM Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: Class II Product Code: KXF Dated: November 1, 2008 Received: November 6, 2008
Dear Dr. Naidu:
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.
3
· Page 2 - Sanjiv H. Naidu, M.D., Ph.D.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for REMI Sciences. The logo is split into two lines, with "REMI" on the first line and "SCIENCES" on the second line. To the right of "REMI" are the words "REGENERATIVE ENGINEERED MATERIAL INNOVATIONS" stacked on top of each other in a smaller font.
Indications for Use
510 (K) Number: K081025
Device Name: IsoelasticU™
Indications for Use:
The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications
- -Rheumatoid arthritis with or without tendon ruptures
- -Degenerative arthritis or post traumatic arthritis
-
- Arthrofibrosis of the DRUJ o
-
- Reconstruction of the distal ulna post tumor resection o
-
- Failed Ulnar Head Resection 0
-
- Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes
-
- Revision following failed ulnar head arthroplasty O
-
- Ulna stems are intended for uncemented use -
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number lo/r/o2x
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REMI Sciences, Inc.
1400 Civic Place, Suite 225
Southlake, Texas 76092
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ph 817-608-9400 ext.1600 fax 817-608-9403 cell 214-641-5171