(285 days)
Not Found
No
The summary describes a hip implant system with a change in the coating application process. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are focused on material and mechanical properties.
Yes
The device, a hip stem system, directly treats mobility-limiting hip diseases, fractures, or defects by replacing damaged parts of the hip, which aligns with the definition of a therapeutic device.
No
Explanation: The device described is a hip stem system intended for total hip replacement, specifically for treating mobility-limiting hip diseases. It is an implantable medical device used in surgical procedures and does not perform any diagnostic functions. The performance studies mentioned are non-clinical tests verifying material properties and coating, not diagnostic accuracy.
No
The device description clearly states that the device is a hip stem made of titanium alloy, which is a physical hardware component. The submission is for a change in the coating of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a hip stem system used for treating mobility-limiting hip diseases, fractures, or defects. This is a surgical implant used in vivo (within the body) to replace or support a damaged hip joint.
- Device Description: The description details a physical implant made of titanium alloy, designed to be combined with other prosthetic components. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue), detect specific substances, or provide diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used to physically replace or support a damaged anatomical structure.
N/A
Intended Use / Indications for Use
The SP-CL Hip Stem and LCU Hip System are indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The hip systems are indicated for the following conditions:
- Primary and secondary coxarthrosis
- Osteoarthritis
- Necrosis of the femoral head
- Femoral neck fractures
The stems are indicated for cementless use only.
Product codes
LZO, MEH
Device Description
The submission includes a straight stem, LCU Hip Sytem, and an anatomically curved stem, SP-CL Hip Stem. Both stems are comprised of titanium alloy (Ti6A14V acc. to ISO 5832-3, ASTM F136) available with HX (CaP) (ASTM F1609) coating. The stems are available in a range of sizes, lengths, and offsets. In total hip replacement, the SP-CL Hip Stem and LCU Hip System are combined with a corresponding prosthesis head and the acetabular implant components manufactured by Waldemar Link. The change that is subject of this 510(k) is to add calcium phosphate coating (CaP) done by Waldemar Link inhouse to the above listed systems. The devices are already commercially available with CaP coating applied by an external vendor. There is no change to the fundamental scientific technology of the referenced hip systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufactured. All components are sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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
Non-clinical performance testing and analysis were provided, including:
- Shear Testing (ASTM F1044-05)
- Tension Testing (ASTM F1147-05)
- Stereological Evaluation (ASTM F1854-15)
- Infrared Spectroscopy
- Dissolution/ Solubility Rate (ASTM F1926/F1926M-14)
- Elemental Analysis (ASTM F1609-08)
- Chemical Analysis (ASTM F1609-08)
- Shelf life
- Endotoxin testing
The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates.
Clinical performance testing was not required to demonstrate the substantial equivalence of this device.
Key Metrics
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 13, 2022
Waldemar Link GmbH & Co. KG % Pia Müller Regulatory Affairs Manager Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, Germany 22844
Re: K213770
Trade/Device Name: SP-CL Hip Stem and LCU Hip 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: August 18, 2022 Received: August 18, 2022
Dear Pia Müller:
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
1
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 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. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213770
Device Name
SP-CL Hip Stem and LCU Hip System
Indications for Use (Describe)
The SP-CL Hip Stem and LCU Hip System are indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The hip systems are indicated for the following conditions:
- Primary and secondary coxarthrosis
- Osteoarthritis
- Necrosis of the femoral head
- Femoral neck fractures
The stems are indicated for cementless use only.
| 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)
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:
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"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."
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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
Pia Müller (Regulatory Affairs Manager)
Oststraße 4-10
Norderstedt, Germany 22844
Phone: +49-40 53995-841
Fax: +49-40 53995-174
E-Mail: p.mueller@linkhh.de |
| Date Prepared: | August 17th, 2022 |
| Trade Name: | SP-CL Hip Stem and LCU Hip System |
| Common Name: | Hip Prosthesis |
| 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 |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | Waldemar Link; LINK SP-CL Hip System
PoroLink (microporous) and HX (CaP) coated & LINK
LCU Hip System PoroLink (microporous) and HX (CaP) coated, K161840 |
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Device Description: The submission includes a straight stem, LCU Hip Sytem, and an anatomically curved stem, SP-CL Hip Stem. Both stems are comprised of titanium alloy (Ti6A14V acc. to ISO 5832-3, ASTM F136) available with HX (CaP) (ASTM F1609) coating. The stems are available in a range of sizes, lengths, and offsets. In total hip replacement, the SP-CL Hip Stem and LCU Hip System are combined with a corresponding prosthesis head and the acetabular implant components manufactured by Waldemar Link. The change that is subject of this 510(k) is to add calcium phosphate coating (CaP) done by Waldemar Link inhouse to the above listed systems. The devices are already commercially available with CaP coating applied by an external vendor. There is no change to the fundamental scientific technology of the referenced hip systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufactured. All components are sterile and for single use only. Indications for Use: The SP-CL Hip Stem and LCU Hip System are indicated for patients with mobility-limiting hip diseases, fractures which cannot be treated by conservative or defects or osteosynthetic procedures. The hip systems are indicated for the following conditions: -Primary and secondary coxarthrosis Osteoarthritis -Necrosis of the femoral head --Femoral neck fractures The stems are indicated for cementless use only. Comparison to the predicate: The SP-CL Hip Stem and LCU Hip System with HX (CaP) inhouse coating are substantially equivalent to LINK SP-CL and LINK LCU Hip System PoroLink (microporous) and HX (CaP) coated (K161840).
The only change of the hip systems is the HX (CaP) coating applied inhouse, which is substantially equivalent to the HX (CaP) coating applied by the external vendor. Features comparable to the predicate devices include the same
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indications, dimensions, materials, packaging, sterilization, surgical implantation technique and intended use.
| Performance Testing: | Non-clinical performance testing and analysis were provided, including: |
|---|---|
| - Shear Testing (ASTM F1044-05)- Tension Testing (ASTM F1147-05)- Stereological Evaluation (ASTM F1854-15)- Infrared Spectroscopy- Dissolution/ Solubility Rate (ASTM F1926/F1926M-14)- Elemental Analysis (ASTM F1609-08)- Chemical Analysis (ASTM F1609-08)- Shelf life- Endotoxin testing | |
| The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates. | |
| Clinical Testing: | Clinical performance testing was not required to demonstrate the substantial equivalence of this device. |
| Conclusion: | The subject devices SP-CL Hip Stem and LCU Hip System with HX (CaP) inhouse coating are substantially equivalent to the predicate device identified in this premarket notification. |