SMS Femoral Stem

K181693 · Medacta International S.A. · LZO · Nov 28, 2018 · Orthopedic

Device Facts

• Record ID: K181693
• Device Name: SMS Femoral Stem
• Applicant: Medacta International S.A.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The hip prosthesis SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia · Avascular necrosis of the femoral head · Acute traumatic fracture of the femoral head or neck · Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip arthroplasty.

Device Story

SMS femoral stem is a cementless, bone-preserving short stem for proximal fixation in total or partial hip arthroplasty. Available in solid standard and lateralized versions. Used in primary or revision surgery. Implanted by orthopedic surgeons in clinical settings. Device integrates into Medacta Total Hip Prosthesis system, connecting to modular femoral heads and acetabular components. Provides structural support for hip joint reconstruction. Benefits patients by restoring joint function and alleviating pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including range of motion (EN ISO 21535), fatigue testing (ISO 7206-4, ISO 7206-6), static load testing (ISO 7206-10), axial disassembly force (ASTM F2009), and coating adhesion/composition testing (ISO 13779-1, ASTM F1147).

Technological Characteristics

Cementless femoral stem for hip arthroplasty. Materials and coatings consistent with predicate devices. Mechanical testing performed per ISO 7206 series and ASTM F2009. Coating testing per ISO 13779-1 and ASTM F1147. Biocompatibility and sterility maintained. No software or electronic components.

Indications for Use

Indicated for patients requiring total or partial hip arthroplasty (primary or revision) due to severely painful/disabled joints from arthritis, rheumatoid polyarthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture of femoral head/neck, or failure of previous hip surgeries.

Regulatory Classification

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.

Predicate Devices

• Zimmer Porolock MIS Stem (K071723)
• MiniMAX (K170845)

Reference Devices

• AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944)
• AMIStem and Quadra - Line Extension (K121011)
• AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794)
• Quadra-H and Quadra-R Femoral Stems (K082792)
• AMIStem-H Proximal Coating (K161635)
• Mpact DM (K143453)
• VersafitCup (K083116 and K092265)
• VersafitCup CC Trio (K103352)
• Mpact (K103721 and K132879)
• Mpact 3D Metal (K171966)
• Medacta Bipolar Head (K091967)
• CoCr ball heads (K072857, K080885 and K103721)
• Endo Head (K111145)
• MectaCer BIOLOX Forte (K073337)
• MectaCer BIOLOX Delta Femoral Heads (K112115)
• MectaCer BIOLOX Option Heads (K131518)

Submission Summary (Full Text)

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November 28, 2018

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K181693

Trade/Device Name: SMS Femoral Stem 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 Codes: LZO, MEH, KWY, LZY Dated: June 26, 2018 Received: June 27, 2018

Dear Chris Lussier:

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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Peter G. Allen -S. The date of the signature is 2018.11.28, and the time is 12:40:28 -05'00'.

Mark N. Melkerson FOR Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K181693

Device Name SMS Cementless Stems

Indications for Use (Describe)

The hip prosthesis SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia

· Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip arthroplasty.

| Type of Use (Select <i>one</i> or <i>both</i> , as applicable) | |
|----------------------------------------------------------------|--|
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

#### I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone] Contact Person: Stefano Baj, Regulatory Affairs Manager, Medacta International SA Date Prepared: June 26, 2018 Date Revised: November 6, 2018

#### II. Device

| Device Proprietary Name: | SMS |
|--------------------------|-----------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Femoral Stems |
| Classification Name: | Hip joint, metal/ceramic/polymer, semi-constrained, cemented or<br>nonporous, uncemented prosthesis |
| Primary Product Code: | |
| Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3360 |
| Device Classification | II |

#### III. Predicate Device

Substantial equivalence is claimed to the following devices:

- 0 Primary Predicate: Zimmer Porolock MIS Stem. K071723, Zimmer GmbH; and
- o Additional Predicate: MiniMAX, K170845, Medacta International SA.

# IV. Device Description

The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery. The SMS implants subject of this submission are comprised of the following products:

- SMS Cementless Solid Standard Stem (available in 11 sizes); and ●
- SMS Cementless Solid Lateralized Stem (available in 11 sizes).

The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), and MiniMAX (K170845).

The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip

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Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polvethylene (HXUHMWPE).

Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).

The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

# V. Indications for Use

The hip prosthesis SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:

- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- 0 Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck ●
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip ● arthroplasty, hip resurfacing replacement or total hip arthroplasty.

# VI. Comparison of Technological Characteristics

The SMS implants and the predicate devices share the following characteristics:

- CCD angle;
- cementless; ●
- material of construction; ●
- coatings and coatings composition;
- biocompatibility;
- device usage: ●
- sterility;
- stem general shape and geometry; ●
- shelf life; and ●
- packaging

SMS is technologically different from the predicate devices as follows:

- sizes; and
- stem lengths. ●

# VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in substantial equivalence

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determination:

Non-Clinical Studies:

- Performance Tests ●
- o range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants;
- o fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including AMENDMENT 1 (2016)];
- o fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants for Surgery Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components;
- o static fatigue testing: ISO 7206-10:2003 Implants for Surgery -- Partial and Total Hip-Joint Prostheses -- Part 10: Determination of Resistance To Static Load of Modular Femoral Heads; and,
- o pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
- Coating Tests
- o ISO 13779-1 Second Edition 2008-10-01 Implants for Surgery Hydroxyapatite Part 1: Ceramic Hydroxyapatite; and,
- o ASTM F1147-99 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings.
- Pyrogenicity ●
- o Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and pyrogen test according to USP chapter <151> for pyrogenicity determination; and,
- o the subject devices are not labeled as non-pyrogenic or pyrogen free.

Clinical Studies:

- No clinical studies were conducted.
# VIII. Conclusion

Based on the above information, the SMS implants are substantially equivalent to the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The SMS implants are as safe and effective as the predicate devices, Zimmer Porolock MIS Stem (K071723) and MiniMAX (K170845).