(140 days)
Not Found
No
The description focuses on the physical components, materials, and surgical use of a radial head implant. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an implant intended to replace the radial head for conditions causing pain and decreased motion, and to reduce or relieve pain and/or improve elbow function, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is an implantable prosthesis (SBi rHead Radial Head, SBi Radial-Capitellar Implant) intended for replacement of the radial head in patients with specific conditions, not for diagnosing those conditions. Its indications for use describe the conditions it treats, not how it diagnoses them.
No
The device description clearly states that the device is an implant made of Cobalt Chrome alloy and Titanium, which are hardware components. It also mentions surgical instruments and trials.
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: The description clearly states that this device is an implant intended to replace the proximal end of the radius (part of the elbow joint). It is a physical device surgically placed within the body.
- Intended Use: The intended use describes the conditions for which the implant is used to treat, such as degenerative joint disease, fractures, and failed previous treatments. This is a therapeutic use, not a diagnostic one.
- Input Imaging Modality: While x-rays are mentioned, they are used to assess the joint condition and guide the surgical placement of the implant, not as the input for a diagnostic test performed by the device itself.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use when used with a hemi-elbow implant:
The SBi rHead Radial Head is indicated for use in 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:
- . Joint destruction or subluxation visible on x-ray
- Resistance to conservative treatment .
Primary replacement after fracture of the radial head
- . Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty .
Indications for use when used with a uni-elbow implant:
The SBi Radial-Capitellar Implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis
- . Inflammatory degenerative joint disease including rheumatoid arthritis
- Correction of functional deformity .
- Revision procedures where other treatments and devices have failed and .
- . Treatment of fractures that are unmanageable using other technologies
Product codes
KWI, JDB
Device Description
The SBirHead, tHead Lateral, and rHead Recon prostheses are implants that are intended to replace the proximal end of the radius. The implants consist of two (2) parts, the head and a stem, which fit together. The rHead™ Standard is designed with a Morse taper coupling mechanism to firmly attach the head onto the stem. The rHead™ RECON is designed with a "ball/socket" (bipolar) coupling mechanism between the head and stem which adds an element of alignment flexibility. The rHead™ Lateral is designed using a dovetail coupling mechanism.
The stem is made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. The radial stem geometry is designed to anatomically fit within the intramedullary canal. The intramedullary surfaces of the stem are roughened to assist in optimal fixation. A version of the stem may be plasma sprayed with a powder titanium coating to further assist in optimal fixation. The extended stem provides additional fixations where excess bone loss due to trauma has occurred. Stems are for cemented or uncemented use when used with the rHead heads.
Each component is supplied in various sizes to support the differences in human anatomies. Each implant can be used in either the right or left arm and the heads and stems are modular.
rHead Radial Head Extended Stems are made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. rHead Radial Head Extended Stems are configured to fit the rHead, rHead Recon, and rHead Lateral heads as well as rHead, rHead Recon, and rHead Lateral heads that fit the Radial Capitellum radial head implants.
The rHead, rHead Lateral, and rHead Recon prostheses are used with trials and surgical instruments including a sterilization tray.
The implants are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial head, elbow
Indicated Patient Age Range
skeletally mature patients
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)
Documentation is provided which demonstrated the SBi rHead™ Radial Head Extended Stems to be substantially equivalent to other legally marketed SBi devices.
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
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K102180 (pg 1/2)
6. 510(k) Premarket Notification Summary of Safety and Effectiveness
Submission Information Manufacturer: Small Bone Innovations, Inc. 1380 South Pennsylvania Avenue Morrisville, PA 19067 Ph: 215-428-1791 Fax: 215-428-1795
DEC 2 0 2010
Submitted By: Small Bone Innovations, Inc. John Minier 1380 South Pennsylvania Avenue Morrisville, PA 19067
Proprietary Name: $BirHead™ Radial Head Extended Stems Classification name: Class II, 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis 888.3160 - Prosthesis, Elbow joint metal/polymer semi-constrained cemented prosthesis Product Code: KWI & JDB Common/Usual Name and Reference Number: Prosthesis, Elbow, Hemi-, Radial, polymer 21 CFR 888.3170 Prosthesis, elbow, semi-constrained, cemented 21 CFR 888.3160
Substantial Equivalence: Documentation is provided which demonstrated the SBi rHead™ Radial Head Extended Stems to be substantially equivalent to other legally marketed SBi devices. The legally marketed predicate devices to which this device is substantially equivalent are the Ascension (K032686) and Tornier (K060438) Radial Head Systems.
Device Description: The SBirHead, tHead Lateral, and rHead Recon prostheses are implants that are intended to replace the proximal end of the radius. The implants consist of two (2) parts, the head and a stem, which fit together. The rHead™ Standard is designed with a Morse taper coupling mechanism to firmly attach the head onto the stem. The rHead™ RECON is designed with a "ball/socket" (bipolar) coupling mechanism between the head and stem which adds an element of alignment flexibility. The rHead™ Lateral is designed using a dovetail coupling mechanism.
The stem is made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. The radial stem geometry is designed to anatomically fit within the intramedullary canal. The intramedullary surfaces of the stem are roughened to assist in optimal fixation. A version of the stem may be plasma sprayed with a powder titanium coating to further assist in optimal fixation. The extended stem provides additional fixations where excess bone loss due to trauma has occurred. Stems are for cemented or uncemented use when used with the rHead heads.
Each component is supplied in various sizes to support the differences in human anatomies. Each implant can be used in either the right or left arm and the heads and stems are modular.
rHead Radial Head Extended Stems are made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. rHead Radial Head Extended Stems are configured to fit the rHead, rHead Recon, and rHead Lateral heads as well as rHead, rHead Recon, and rHead Lateral heads that fit the Radial Capitellum radial head implants.
1
The rHead, rHead Lateral, and rHead Recon prostheses are used with trials and surgical instruments including a sterilization tray.
The implants are intended for single use only.
Intended use of the extended stems when used as a hemi-elbow implant:
The SBi rHead Radial Head is indicated for use in 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:
- . Joint destruction or subluxation visible on x-ray
- . Resistance to conservative treatment
Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty
Intended use of the extended stems when used with a uni-elbow implant:
The SBi Radial-Capitellar Implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions:
Non-inflammatory degenerative joint disease including osteo-arthritis or traumatic . arthritis
- Inflammatory degenerative joint disease including rheumatoid arthritis ●
- Correction of functional deformity
- Revision procedures where other treatments and devices have failed and •
- . . Treatment of fractures that are unmanageable using other technologies
Materials: rHead Radial Head Extended Stem is made from implant grade Cobalt Chrome alloy (CoCrMo) per ASTM F1537. The intramedullary stem portion of the stem may be coated by plasma spray. The raw material of the plasma spray is a titanium powder per ASTM F1580.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Small Bone Innovations, Inc. % Mr. John Minier l 380 South Pennsylvania Avenue Morrisville, PA 19067
Re: K102180
Trade/Device Name: SBi rHead™ Radial Head Extended Stems Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint netal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Regulatory Class: II Product Code: JDB, KWI Dated: November 18, 2010 Received: November 19, 2010
DEC 2 0 2010
Dear Mr. Minier:
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 (Act do not require approval of the Pederal Frood, Drug,
You may, therefore, market the device as the secure 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 misting
adulteration . Please nota, CDDL . 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 of class In (PMA)
found in the Code of Foderal Reviews affective major regulations affecting your device can 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
3
Page 2 - Mr. John Minier
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (ZI CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (217)FB, 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5. Statement of Indications for Use
510(k) Number: K102180 (pg | /۱ )
Device Name: SBi rHead Radial Head Extended Stem
Indications for use when used with a hemi-elbow implant:
The SBi rHead Radial Head is indicated for use in 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:
- . Joint destruction or subluxation visible on x-ray
- Resistance to conservative treatment .
Primary replacement after fracture of the radial head
- . Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty .
Indications for use when used with a uni-elbow implant:
The SBi Radial-Capitellar Implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease including osteo-arthritis or traumatic � arthritis
- . Inflammatory degenerative joint disease including rheumatoid arthritis
- Correction of functional deformity .
- Revision procedures where other treatments and devices have failed and .
- . Treatment of fractures that are unmanageable using other technologies
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) for M. Mehrer
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102180