ISOELASTICU

• K Number: K081025
• Device Name: ISOELASTICU
• Manufacturer: REMI SCIENCES, INC.
• Date Cleared: 2008-11-21 ( 225 days)
• Product Code: KXE , KXF
• Regulation Number: 888.3810
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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
  • 1. Arthrofibrosis of the DRUJ o
  • 2. Reconstruction of the distal ulna post tumor resection o
  • 3. Failed Ulnar Head Resection 0
  • 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes
  • 5. Revision following failed ulnar head arthroplasty O
• Ulna stems are intended for uncemented use -

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.

AI/ML Overview

This document is a 510(k) summary for a medical device (IsoelasticU™ wrist joint ulnar prosthesis). It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, standalone algorithm performance, or training set details).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (SBI Uhead Implant). This is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device or AI/software.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. No Acceptance Criteria or Reported Device Performance Table: The document explicitly states that the device is "substantially equivalent" to the SBI Uhead Implant. The table provided compares features and indications for use between the IsoelasticU and the predicate device, not performance metrics against acceptance criteria.
2. No Study Described: There is no description of a clinical study, algorithm performance study, or any kind of test set evaluation to demonstrate the IsoelasticU™ meets specific performance metrics.
3. No AI Mentioned: The device is a physical prosthesis, not an AI or software device. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," or "standalone algorithm performance" are not applicable to this document.
4. Regulatory Approach: The 510(k) process for this device relies on demonstrating that it is as safe and effective as a legally marketed predicate device, not on proving new performance against predefined quantitative criteria through a performance study.

In summary, the provided text does not contain the information required to answer your prompt because it is a 510(k) summary for a physical medical device (a prosthesis) that demonstrates substantial equivalence, not a performance study for an AI/software device or a novel device proving specific acceptance criteria.

Summary

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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: [phone] Fax: [phone] 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
    • 2. Reconstruction of the distal ulna post tumor resection ୍
    • 3. Failed Ulnar Head Resection
    • 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory o changes
    • 5. Revision following failed ulnar head arthroplasty o

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 [phone] cell 214-641-5171

[e-mail] www.remisciences.com

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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 arthritis1. Arthrofibrosis of the DRUJ2. Reconstruction of the distal ulna post tumor resection3. Failed Ulnar Head Resection4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory changes5. 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 [phone] cell 214-641-5171

[e-mail] www.remisciences.com

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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.

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· 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 [phone]. 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 [phone] or [phone] 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

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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
  • 1. Arthrofibrosis of the DRUJ o
  • 2. Reconstruction of the distal ulna post tumor resection o
  • 3. Failed Ulnar Head Resection 0
  • 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes
  • 5. 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 [phone] cell 214-641-5171

[e-mail] www.remisciences.com

Regulation Number and Section

§ 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.