(378 days)
No
The document describes manual surgical instruments and explicitly states that the modifications do not involve any change in technology. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The document describes "BiMobile instruments," which are manual orthopedic surgical reusable instruments used to aid the implantation of the BiMobile Dual Mobility System. While the dual mobility system itself is therapeutic, these specific instruments are tools for implantation, not a device that directly provides therapy.
No
Explanation: The device is a surgical instrument system used for the implantation of a hip joint system, not for diagnosing medical conditions.
No
The device is described as manual orthopedic surgical reusable instruments, which are physical hardware components used in surgery.
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 system (BiMobile Dual Mobility System) and the instruments used to implant it. It addresses conditions of the hip joint and proximal femur, which are anatomical structures within the body.
- Device Description: The device is described as "manual orthopedic surgical reusable instruments" used to aid in the implantation of a surgical system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of hip joint or proximal femur, which cannot be treated by conservative or osteosynthetic procedures.
The BiMobile Dual Mobility System is indicated for the following conditions:
- · Primary and secondary coxarthrosis
- Rheumatoid arthritis
- · Correction of functional deformities
- · Avascular Necrosis
- · Femoral neck fractures
- · Revision after implant loosening dependent on bone mass and quality
- · Dislocation risks
The device is intended for cemented and cementless use.
Product codes
LZO, MEH
Device Description
The BiMobile instruments are considered a line extension to the instrument system cleared in 510(k) K171273 and K190535 with the BiMobile Dual Mobility System. Like the original instruments, the additional BiMobile instruments are manual orthopedic surgical reusable instruments offered to aid the implantation of the BiMobile Dual Mobility System (K171273 and K190535). The BiMobile Instruments incorporate design changes for simplicity of use. The modifications do not significantly alter the surgical workflow or technique, the intended use, or involve any change in technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint or proximal femur
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)
The substantial equivalence of the modified to the original instruments was supported by non-clinical testing and evaluations including:
- -Simulated transport testing
- Biocompatibility assessment -
- Interface analysis, functional testing, biolab evaluation, application risk analysis
- -Durability testing
- -Validation of reprocessing and sterilization instructions
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
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June 3, 2022
Waldemar Link GmbH & Co. KG Stefanie Fuchs Regulatory Affairs Oststraße 4-10. Norderstedt, DEU 22844
Re: K211567
Trade/Device Name: BiMobile Instruments (for use with Dual Mobility System) Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: May 21, 2021 Received: May 21, 2021
Dear Stefanie Fuchs:
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.
1
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.
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211567
Device Name
BiMobile Instruments (for use with BiMobile Dual Mobility System)
Indications for Use (Describe)
The BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of hip joint or proximal femur, which cannot be treated by conservative or osteosynthetic procedures.
The BiMobile Dual Mobility System is indicated for the following conditions:
- · Primary and secondary coxarthrosis
- Rheumatoid arthritis
- · Correction of functional deformities
- · Avascular Necrosis
- · Femoral neck fractures
- · Revision after implant loosening dependent on bone mass and quality
- · Dislocation risks
The device is intended for cemented and cementless use.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration #:3003386935 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Stefanie Fuchs (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: st.fuchs@linkhh.de |
| Date Prepared: | June 2, 2022 |
| Trade Name: | BiMobile Instruments (for BiMobile Dual Mobility System) |
| Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or
non-porous; 21 CFR §888.3353, product code LZO
Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-
porous, calcium-phosphate; 21 CFR §888.3353, product code MEH |
| Predicate Devices: | LINK BiMobile Dual Mobility System, K171273, cleared January 19,
2018
LINK BiMobile Dual Mobility System – E-Dur Inserts, K190535,
cleared August 6, 2019 |
| Device Description: | The BiMobile instruments are considered a line extension to the
instrument system cleared in 510(k) K171273 and K190535 with the
BiMobile Dual Mobility System. Like the original instruments, the
additional BiMobile instruments are manual orthopedic surgical
reusable instruments offered to aid the implantation of the BiMobile
Dual Mobility System (K171273 and K190535). The BiMobile
Instruments incorporate design changes for simplicity of use. The
modifications do not significantly alter the surgical workflow or
technique, the intended use, or involve any change in technology. |
| Indications for Use: | The BiMobile Dual Mobility System is indicated for patients with
mobility-limiting diseases, fractures or defects of hip joint or proximal
femur, which cannot be treated by conservative or osteosynthetic
procedures. |
4
The BiMobile Dual Mobility System is indicated for the following conditions:
- . Primary and secondary coxarthrosis
- . Rheumatoid arthritis
- . Correction of functional deformities
- Avascular Necrosis
- Femoral neck fractures .
- . Revision after implant loosening dependent on bone mass and quality
- . Dislocation risks
The device is intended for cemented and cementless use.
Technological Characteristics and Substantial Equivalence
The modified Class II accessory instruments within the BiMobile Instrument system that are the subjects of this 510(k) have the same intended use, operating principle, basic device designs and purposes, and materials as the unmodified instruments. The modified impactor handles with the corresponding impactor expanders create the same impaction of the shells, but feature minor design changes for simplicity and ease of use. The substantial equivalence of the modified to the original instruments was supported by non-clinical testing and evaluations including:
- -Simulated transport testing
- Biocompatibility assessment -
- Interface analysis, functional testing, biolab evaluation, application risk analysis
- -Durability testing
- -Validation of reprocessing and sterilization instructions
The subject BiMobile Instruments that are subject of this 510(k) Conclusion: (Class II accessory instruments) are substantially equivalent to the predicate instruments identified in this premarket notification.