(129 days)
Not Found
No
The 510(k) summary describes a mechanical implant and its associated instruments, with the focus of the submission being on MR Conditional labeling. There is no mention of AI, ML, image processing for analysis, or any data sets for training or testing algorithms.
Yes
The device is a radial head replacement system used to alleviate pain, crepitation, and decreased motion, which are therapeutic effects for patients with degenerative or post-traumatic disabilities.
No
The device is a radial head replacement implant, designed for surgical treatment of joint issues, not for diagnosing them.
No
The device description clearly states it is a physical implant (Radial Head Replacement System Implant) made of wrought CoCrMo alloy, along with accessory instruments. It also describes non-clinical testing related to the physical properties of the implant in an MR environment. This is a hardware device, not software only.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "Radial Head Replacement System Implant" used for the surgical replacement of the radial head in the elbow joint. This is an implantable medical device used in vivo (within the body) for structural support and function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
• 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: o joint destruction and/or subluxation visible on x-ray; and/or - o 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
KWI
Device Description
This document is regarding the DePuy Synthes Radial Head Replacement System-MR Conditional. The Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 –24mm in length. The Radial Head is manufactured from wrought CoCrMo alloy. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone. The devices in scope of the subject submission are being reviewed for MR Conditional labeling in addition to the previously cleared indications for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray, MR
Anatomical Site
radio-humeral and/or proximal radio-ulnar joint (elbow joint, radial head)
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)
This submission includes non-clinical testing to support the conditional safety of the DePuy Synthes Radial Head Implants in the Radial Head Replacement System in the MR environment. The testing includes magnetically induced displacement force (ASTM F2052-15) and torque (ASTM F2213-17), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07 (2013)). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2022
DePuy Synthes Quinn Mccarthy Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester. Pennsylvania 19380
Re: K213563
Trade/Device Name: DePuy Synthes Radial Head Replacement System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow Joint Radial (Hemi-Elbow) Polymer Prosthesis Regulatory Class: Class II Product Code: KWI Dated: January 28, 2022 Received: January 31, 2022
Dear Quinn Mccarthy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lixin Liu, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213563
Device Name
DePuy Synthes Radial Head Replacement System
Indications for Use (Describe)
•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:
o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- · Revision following failed radial head arthroplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red graphic element on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in smaller letters, with "Johnson & Johnson" in red.
510(k) Summary
| Sponsor | DePuy Synthes
Quinn McCarthy
1301 Goshen Parkway
West Chester, PA 19380
Phone: (732) 947 2251 |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | March 04, 2022 |
| Proprietary Name | DePuy Synthes Radial Head Replacement System – MR Conditional |
| Classification Name | Elbow joint radial (hemi elbow) polymer prosthesis |
| Classification | Class II
Regulation Number: 21 CFR §888.3170
Product Code: KWI |
| Predicate Device | Revolution Radial Head - K183618 |
| Device Description | This document is regarding the DePuy Synthes Radial Head
Replacement System-MR Conditional. The Radial Head Replacement
System Implant is a one-piece, stemmed radial head replacement. The
radial head is available in diameters of 19, 22 and 25mm. The radial
stems range from 5.5 to 8.5mm in diameter and from 21 –24mm in
length. The Radial Head is manufactured from wrought CoCrMo alloy.
The system is provided with a set of accessory instruments designed for
preparation of the implant site and insertion of the implants into bone.
The devices in scope of the subject submission are being reviewed for
MR Conditional labeling in addition to the previously cleared
indications for use. |
| Indications for Use | 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 visible on x-ray; and/or resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. |
| Image: THE ORTHOPAEDICS COMPANY OF Johnson & Johnson | |
| Contraindications | Absolute contraindications include: Infection, sepsis, osteomyelitis.
Relative contraindications include: Uncooperative patient or patient
with neurologic disorders who are incapable of following directions,
osteoporosis, metabolic disorders which may impair bone formation,
osteomalacia, distant foci of infections which may spread to the
implant site, rapid joint destruction, marked bone loss or bone
resorption apparent on roentgenogram |
| Comparison to
Predicate | The purpose of this submission is to add MR Conditional information to
the device labeling for the DePuy Synthes Radial Head Replacement
System - MR Conditional, K183618. The intended use and
technological characteristics of the devices remains unchanged. The
device name has been updated to reflect the current company name,
DePuy Synthes, previously cleared as the Revolution Radial Head and
now renamed to the DePuy Synthes Radial Head Replacement System -
MR Conditional.
The materials of the devices remain unchanged from K183618 (CoCrMo
alloy conforming to ASTM F1537).
The technical characteristics of the device remain unchanged from the
predicate K183618:
One-piece Head diameters of 19, 22 and 25mm Head Heights of 9-15, 10-16, 11-17mm Stem diameters 5.5 – 8.5mm Stem lengths 21-24mm Radial head thickness 9 – 17mm Articular depth 1.6 – 2.6mm |
| Non-Clinical
Performance Data | This submission includes non-clinical testing to support the conditional
safety of the DePuy Synthes Radial Head Implants in the Radial Head
Replacement System in the MR environment. The testing includes
magnetically induced displacement force (ASTM F2052-15) and torque
(ASTM F2213-17), radio frequency (RF) heating (ASTM F2182-11a), and
image artifacts (ASTM F2119-07 (2013)). The non-clinical performance
data demonstrate that the subject devices, when exposed to the MR
environment under specific MR conditions of use, raise no different
questions of safety or effectiveness. |
| Clinical
Performance Data | Clinical testing was not necessary for the determination of substantial
equivalence. |
| Substantial
Equivalence | The subject device has the same intended use compared to the
predicate device. The technological characteristics of the device remain
unchanged. |
| | It is concluded that the information provided herein supports
substantial equivalence of the subject devices to the predicate device,
K183618. |
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Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red symbol on the left, followed by the company name in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF Johnson & Johnson" in a smaller font.