(182 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical implant for radial head replacement, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is a radial head replacement system used to treat pain, crepitation, and decreased motion due to joint destruction, resistance to conservative treatment, fractures, or failed arthroplasty, indicating a therapeutic purpose.
No
The device is a radial head replacement system, which is a prosthetic device used for surgical implantation, not for diagnosing medical conditions.
No
The device description explicitly states it is a modular prosthesis consisting of metallic and porous tantalum components, which are hardware.
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. They are used outside of the body.
- Device Description: The Implex Radial Head Replacement System is a prosthetic implant designed to be surgically placed inside the body to replace a damaged radial head.
- Intended Use: The intended use clearly states it's for the "Replacement of the radial head" due to various conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Implex Radial Head Replacement System is indicated for:
• Cemented Use Only.
• Replacement of the radial head for degenerative or post-
traumatic disabilities presenting pain, crepitation, and
decreased motion at the radio-humeral and/or proximal
radio-ulnar joint with:
-Joint destruction and/or subluxation.
-Resistance to conservative treatment.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KWI
Device Description
The Implex Radial Head Replacement System is a modular prosthesis consisting of a metallic head and a Hedrocel porous tantalum stem. The metallic head component is offered in three diameter options of 16, 21, and 26 mm. each with 4 head extension lenaths. The articulating surface of the head component is offered in Co-Cr-Mo alloy. The stem component is offered in three cross sectional sizes of 7, 9, and 11 mm, with corresponding stem lengths of 23, 30, and 37 mm, respectively. All stem size options are compatible with all head size options. The Implex Radial Head Replacement System is a modular system, and the metallic head must be inter-operatively cemented to the Hedrocel stem using PMMA bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radio-humeral and/or proximal radio-ulnar 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)
Performance testing of the cemented modular assembly was performed, and the results indicate that the assembly possesses a high degree of mechanical integrity.
Additionally, the Implex Radial Head is manufactured from materials with known performance characteristics (MAF #920) and properties which are typically used in total joint arthroplasty.
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.
Not Found
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
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.
0
| JUN 1 1999 | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|---|
| Implex Radial Head Replacement System | ||
| Submitter Name: | Implex Corp. | |
| Submitter Address: | 80 Commerce Drive | |
| Allendale, New Jersey 07401-1600 | ||
| Contact Person: | John Schalago or Robert Poggie, Ph.D. | |
| Phone Number: | (201) 818-1800 | |
| Fax Number: | (201) 818-0567 | |
| Date Prepared: | April 19, 1999 | |
| Device Trade Name: | Radial Head Surface Replacement | |
| Device Common Name: | Elbow joint humeral (hemi-elbow) prosthesis | |
| Classification Number | ||
| and Name: | 21 CFR § 888.3170 |
Substantial Equivalence: The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
Device Description: The Implex Radial Head Replacement System is a modular prosthesis consisting of a metallic head and a Hedrocel porous tantalum stem. The metallic head component is offered in three diameter options of 16, 21, and 26 mm. each with 4 head extension lenaths. The articulating surface of the head component is offered in Co-Cr-Mo alloy. The stem component is offered in three cross sectional sizes of 7, 9, and 11 mm, with corresponding stem lengths of 23, 30, and 37 mm, respectively. All stem size options are compatible with all head size options. The Implex Radial Head Replacement System is a modular system, and the metallic head must be inter-operatively cemented to the Hedrocel stem using PMMA bone cement.
1
| 510(k) Summary of Safety and Effectiveness, Continued | |
|---|---|
| Indications for Use: | The Implex Radial Head Replacement System is indicated for: |
| • Cemented Use Only. | |
| • Replacement of the radial head for degenerative or post- | |
| traumatic disabilities presenting pain, crepitation, and | |
| decreased motion at the radio-humeral and/or proximal | |
| radio-ulnar joint with: | |
| -Joint destruction and/or subluxation. | |
| -Resistance to conservative treatment. | |
| • Primary replacement after fracture of the radial head. | |
| • Symptomatic sequelae after radial head resection. | |
| • Revision following failed radial head arthroplasty. | |
| Predicate Device | |
| Information: | The Implex Radial Head Replacement System is |
| substantially equivalent to Wright Medical Technology, | |
| Metallic Radial Heads, and the Avanta Orthopedics, Avanta | |
| RHTM. | |
| Device Technological | |
| Characteristics and | |
| Comparison to | |
| Predicate Device: | A comparison of device characteristics (materials, design, |
| configuration, and indications for use) included in this 510(k) | |
| Premarket Notification supports a substantial equivalence | |
| determination. | |
| Performance Data: | Performance testing of the cemented modular assembly was |
| performed, and the results indicate that the assembly | |
| possesses a high degree of mechanical integrity. | |
| Additionally, the Implex Radial Head is manufactured from | |
| materials with known performance characteristics (MAF | |
| #920) and properties which are typically used in total joint | |
| arthroplasty. | |
| Conclusion: | The Implex Radial Head Replacement System is |
| substantially equivalent to the identified predicate devices. |
、
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1999
John A. Schalago, RAC Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K984290 Trade Name: Implex Radial Head Replacement System Regulatory Class: II Product Code: KWI Dated: April 20, 1999 Received: April 21, 1999
Dear Mr. Schalago:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - John A. Schalago, RAC
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
Implex Radial Head Replacement System
Indications For Use:
The Implex Radial Head Replacement System indications for use are as follows:
-
. For Cemented Use Only.
: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -
Replacement of the radial head for degenerative or post-traumatic . disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with:
- a) Joint destruction and/or subluxation.
- b) Resistance to conservative treatment.
-
. Primary replacement after fracture of the radial head.
-
Symptomatic sequelae after radial head resection. .
-
Revision following failed radial head arthroplasty. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR...
Over-The-Counter Use
(Optional Format 1-2-96)
Piazzale
(Division Sign-Off) Division of General Restorative Devices 12984290 510(k) Number .