(107 days)
Not Found
No
The document describes a mechanical implant and surgical instrumentation, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is a radial head prosthesis designed to replace the radial head for various disabilities and conditions, which aligns with the definition of a therapeutic device aimed at treating or alleviating medical conditions.
No
This device is a radial head prosthesis designed for replacement and revision surgeries, not for diagnosing medical conditions.
No
The device description clearly states that the Align Radial Head System is comprised of physical components: multiple sized CoCr Radial Heads with Locking Screw, multiple sized titanium alloy Stems, and system specific instrumentation. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the radial head in the human body. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a prosthesis (artificial body part) and associated surgical instruments. This aligns with a medical device used in surgery, not a diagnostic kit or instrument for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
In Vitro Diagnostics (IVDs) are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is an implantable medical device used for surgical treatment.
N/A
Intended Use / Indications for Use
The Align Radial Head System and accessories are designed specifically for
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,
- 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.
The system is intended for press fit use.
Product codes (comma separated list FDA assigned to the subject device)
KWI
Device Description
The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.
The Align Radial Head System is comprised of:
- · Multiple sized CoCr Radial Heads with Locking Screw
- Multiple sized titanium alloy Stems, titanium plasma spray coated
- · System specific instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
radial head, radio-humeral and/or proximal radio-ulnar joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical analysis and testing demonstrated that the Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2017 Skeletal Dynamics, LLC Ana Escagedo President 8905 SW 87 Avenue, Suite 201 Miami, Florida 33176
Re: K172688
Trade/Device Name: Align Radial Head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow Joint Radial (Hemi-Elbow) Polymer Prosthesis Regulatory Class: Class II Product Code: KWI Dated: November 17, 2017 Received: November 22, 2017
Dear Ana Escagedo:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172688
Device Name ALIGN Radial Head System
Indications for Use (Describe)
The Align Radial Head System and accessories are designed specifically for
· 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,
- 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.
The system is intended for press fit use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness Skeletal Dynamics Align Radial Head System
September 5, 2017
Submitter:
Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo, Vice President Email: aescagedo@skeletaldynamics.com
Establishment Registration Number: 3006742481
Name and Classification:
| Name | Align Radial Head System |
|---|---|
| Common Name | Elbow Hemi Prosthesis, Radial Head |
| Classification | 21 CFR §888.3170 |
| Product Code | KWI |
| Class | Class II |
Predicate Devices:
Align Radial Head System (K092721)
Description of the Device:
The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.
The Align Radial Head System is comprised of:
- · Multiple sized CoCr Radial Heads with Locking Screw
- Multiple sized titanium alloy Stems, titanium plasma spray coated
- · System specific instrumentation.
4
Intended Use:
The Align Radial Head System and accessories are designed specifically for
- 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.
- 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. 0
The system is intended for press fit use.
Technoloqical Characteristics:
The substantial equivalence of the Align Radial Head System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness.
Performance Testing:
Preclinical analysis and testing demonstrated that the Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.
Conclusion:
The Skeletal Dynamics Align Radial Head System is substantially equivalent to the predicate device identified in this premarket notification.