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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device (SP-CL Hip Stem and LCU Hip System) and is primarily focused on demonstrating substantial equivalence to a predicate device rather than undergoing a new, rigorous clinical performance study with predefined acceptance criteria for a novel AI/software device.

Therefore, the information requested in your prompt regarding acceptance criteria for device performance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this type of FDA submission. This submission is for a physical orthopedic implant seeking to demonstrate that a change in manufacturing (applying a coating in-house instead of by an external vendor) does not alter its safety or efficacy compared to an already cleared device.

However, I can extract the relevant information that is available in the document:

1. A table of (implied) acceptance criteria and the reported device performance

Since this is a 510(k) for an orthopedic implant and not a novel AI device, the "acceptance criteria" are not about AI performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance criteria are met by demonstrating that the modifications (in-house CaP coating) do not negatively impact the physical and chemical properties of the hip stems compared to the predicate device.

Implied Acceptance Criteria (Demonstrates Equivalence)	Reported Device Performance (Summary of Non-Clinical Testing Results)
Mechanical Properties:
Shear strength of coating adhesion (ASTM F1044-05)	Results demonstrate suitability for intended purpose and substantial equivalence to predicates.
Tension strength of coating adhesion (ASTM F1147-05)	Results demonstrate suitability for intended purpose and substantial equivalence to predicates.
Material Properties:
Coating morphology and structure (Stereological Evaluation - ASTM F1854-15)	Results demonstrate suitability for intended purpose and substantial equivalence to predicates.
Chemical composition of coating (Infrared Spectroscopy, Elemental Analysis - ASTM F1609-08, Chemical Analysis - ASTM F1609-08)	Results demonstrate suitability for intended purpose and substantial equivalence to predicates.
Coating dissolution/solubility rate (ASTM F1926/F1926M-14)	Results demonstrate suitability for intended purpose and substantial equivalence to predicates.
Biocompatibility/Sterility:
Endotoxin levels	Results demonstrate suitability for intended purpose and substantial equivalence to predicates.
Product Stability:
Shelf life	Results demonstrate suitability for intended purpose and substantial equivalence to predicates.

The study that "proves the device meets the acceptance criteria" is the non-clinical performance testing conducted by the manufacturer. The conclusion is that "The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates."

The remaining points (2-9) are largely not applicable to this type of 510(k) submission for a physical implant with a manufacturing change.

2. Sample size used for the test set and the data provenance: Not applicable. Testing involved material samples of the implants, not a "test set" of patient data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The "truth" is established by adherence to ASTM standards for material testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. The "ground truth" for this device's performance is derived from its adherence to established material and mechanical testing standards (e.g., ASTM F1044-05 for shear testing, ASTM F1609-08 for elemental analysis).
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

In summary, this 510(k) submission relies on non-clinical engineering and material science testing to demonstrate substantial equivalence, rather than clinical studies or evaluations of AI performance.

Summary

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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

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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.

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510(k) Summary

510(k) Submitter:	Waldemar Link GmbH & CO. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration #:3003386935
Contact Person:	Waldemar Link GmbH & Co. KGPia Müller (Regulatory Affairs Manager)Oststraße 4-10Norderstedt, Germany 22844Phone: +49-40 53995-841Fax: +49-40 53995-174E-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 codeLZOProsthesis, 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 SystemPoroLink (microporous) and HX (CaP) coated & LINKLCU 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.

Regulation Number and Section

§ 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.