(140 days)
Not Found
No
The 510(k) summary describes a modular hip prosthesis system and its components. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML in the device's function or design. The performance studies are non-clinical mechanical tests.
Yes
The device is a modular hip prosthesis system intended for revision hip arthroplasty, which is a medical procedure to treat conditions like bone defects, loosened femoral prosthetics, or deformed proximal femurs. As it is used for treatment and correction of medical conditions, it qualifies as a therapeutic device.
No
The device is a modular hip prosthesis system intended for revision hip arthroplasty, which is a treatment/reconstruction device, not a diagnostic one.
No
The device description clearly states it is a modular hip prosthesis system consisting of physical components like stems, heads, and neck segments made of materials like Titanium and Cobalt Chromium. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant used for hip reconstruction. It is a physical device implanted into the patient's body to replace or augment bone structure.
- Intended Use: The intended use clearly states it's for "revision hip arthroplasty" in patients with poor bone stock. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a medical device, specifically a prosthetic implant, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The MP Reconstruction System is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The MP Reconstruction System is indicated for the following conditions:
-
Revision arthroplasty due to juxta-articular bone defects.
-
Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone.
-
Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture.
-
Deformed proximal femur due to fractures or osteotomies.
-
Correction of bone deficiencies, e.g. due to tumors.
-
Large post-revision and post-trauma segmental bone defects.
The MP Reconstruction System is for cementless use. Only cemented labeled modular stems are indicated for cemented use.
Product codes
LZO, JDI
Device Description
This 510k adds Cemented Stems to the MP Reconstruction System.
The MP Reconstruction System is a modular hip prosthesis system and consists of Prosthesis Heads, Stems, Neck Segments, Proximal Spacers, and Expansion Bolts. The modular components are interchangeable allowing for independent positioning. The Prosthesis Stems are available in a variety of diameters and lengths. Neck Segments are available in a variety of CCD angles and sizes. Proximal Spacers are available in two different heights and can be used independently or combined to add leg length. Expansion Bolts are used to secure the Neck Segments and Proximal Spacers, when used, to the Prosthesis Stems.
The cementless prosthesis stems are tapered with a microporous surface, and include longitudinal fluting. The cemented prosthesis stems have a rounded triangular shape with an anatomic bow at the distal tip.
The MP Reconstruction Prosthesis Stems (cementless) and Neck Segments are produced of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). Cemented Stems, Proximal Spacers and Expansion Bolts are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, neck, or portions of the proximal femur; hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical performance testing was conducted with consideration to Guidance for Industry and FDA Staff, Non-Clinical Information for Femoral Stem Prosthesis, September 17, 2007 and Guidance Document For Testing Non-Articulating,"Mechanically Locked", Modular Implant Components, May 1, 1995.
Non-clinical performance testing included: femoral stem fatigue tests per ISO 7206-4.
The results of non-clinical performance testing demonstrated that the device is substantially equivalent to the predicate devices.
There was no clinical performance testing required for this device.
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 11, 2022
Waldemar Link GmbH & Co. KG Lydia Ditter Regulatory Affairs Ostsraße 4-10 Norderstedt. 22844 Germany
Re: K213675
Trade/Device Name: MP Reconstruction 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, JDI Dated: April 8, 2022 Received: April 8, 2022
Dear Lydia Ditter:
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.
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
1
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 (OS) 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 mediation-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
2
Indications for Use
510(k) Number (if known) K213675
Device Name MP Reconstruction System
Indications for Use (Describe)
The MP Reconstruction System is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The MP Reconstruction System is indicated for the following conditions:
-
Revision arthroplasty due to juxta-articular bone defects.
-
Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone.
-
Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture.
-
Deformed proximal femur due to fractures or osteotomies.
-
Correction of bone deficiencies, e.g. due to tumors.
-
Large post-revision and post-trauma segmental bone defects.
The MP Reconstruction System is for cementless use. Only cemented labeled modular stems are indicated for cemented use.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & CO. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration #:3004371426 (Oststraße 4-10) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Lydia Ditter (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: L.Ditter@linkhh.de |
| Date Prepared: | April 11, 2022 |
| Trade Name: | MP Reconstruction System |
| Common Name: | Hip Revision Prosthesis |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis 21 CFR
§ 888.3353, product code LZO
Hip joint metal/polymer semi-constrained cemented
prosthesis; 21 CFR §888.3350, product code JDI |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | LINK MP Reconstruction Hip (K142187) - Primary
Predicate
LINK MEGASYSTEM-C (K151008) |
| Device Description: | This 510k adds Cemented Stems to the MP
Reconstruction System.
The MP Reconstruction System is a modular hip
prosthesis system and consists of Prosthesis Heads,
Stems, Neck Segments, Proximal Spacers, and
Expansion Bolts. The modular components are
interchangeable allowing for independent positioning.
The Prosthesis Stems are available in a variety of
diameters and lengths. Neck Segments are available in
a variety of CCD angles and sizes. Proximal Spacers are
available in two different heights and can be used |
4
independently or combined to add leg length. Expansion Bolts are used to secure the Neck Segments and Proximal Spacers, when used, to the Prosthesis Stems.
The cementless prosthesis stems are tapered with a microporous surface, and include longitudinal fluting. The cemented prosthesis stems have a rounded triangular shape with an anatomic bow at the distal tip.
The MP Reconstruction Prosthesis Stems (cementless) and Neck Segments are produced of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). Cemented Stems, Proximal Spacers and Expansion Bolts are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.
The MP Reconstruction Prosthesis is intended for Indications for Use: revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The MP Reconstruction Hip Prosthesis is indicated for the following conditions:
-
- Revision arthroplasty due to juxta-articular bone defects.
-
- Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone.
-
- Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture.
-
- Deformed proximal femur due to fractures or osteotomies.
- Correction of bone deficiencies, e.g. due to tumors. 5)
-
- Large post-revision and post-trauma segmental bone defects.
The MP Reconstruction Prosthesis is for cementless use. Only cemented labeled modular stems are indicated for cemented use.
Comparison to Predicate Device: The subject device has the same indications for use as the primary predicate, but includes the option of cemented stems. The subject device is made of materials identical to those used in the predicate and reference device systems. The subject device cemented prosthesis stems differ from the primary predicate cementless prosthesis stems in that the cemented stems are made of CoCrMo instead of Ti-6AI-4V and have a modified stem shaft design intended for use with bone
5
cement: They are cylindrical with 3 flattened sides, giving them a rounded triangular shape and a narrower distal tip with a slight bow.
The performance testing is sufficient to demonstrate that the subject and predicate devices are substantially equivalent with regard to design. Any difference between the subject and predicate device does not change the intended use or fundamental scientific technology.
Performance Data: Non-Clinical Performance and Conclusions:
Non-Clinical performance testing was conducted with consideration to Guidance for Industry and FDA Staff, Non-Clinical Information for Femoral Stem Prosthesis, September 17, 2007 and Guidance Document For Testing Non-Articulating,"Mechanically Locked", Modular Implant Components, May 1, 1995.
Non-clinical performance testing included: femoral stem fatigue tests per ISO 7206-4.
The results of non-clinical performance testing demonstrated that the device is substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
There was no clinical performance testing required for this device.
Conclusion: The subject device cemented prosthesis stem of the MP Reconstruction System is substantially equivalent to the predicate devices identified in this premarket notification.