MINIMA S SYSTEM

K141327 · Lima Corporate S.P.A. · LZO · Aug 6, 2014 · Orthopedic

Device Facts

• Record ID: K141327
• Device Name: MINIMA S SYSTEM
• Applicant: Lima Corporate S.P.A.
• Product Code: LZO · Orthopedic
• Decision Date: Aug 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; - rheumatoid arthritis; - treatment of femoral head and neck fractures; - revisions in cases of good remaining femoral bone stock.

Device Story

Minima S System is a monolithic, collarless, cementless femoral hip prosthesis; available in 9 sizes with standard/lateralized versions. Stem manufactured from Ti6Al4V with proximal plasma-sprayed titanium coating; features 12/14 conical taper for coupling with Biolox Delta ceramic heads or Lock Bipolar heads. Designed for press-fit insertion into femoral canal; rectangular section and V-shaped A-P profile improve bone morphology adaptability. Used by orthopedic surgeons in clinical settings for total or partial hip arthroplasty. Provides structural replacement of femoral head/neck to restore hip function and reduce pain. Biolox Delta heads articulate with acetabular components (e.g., Delta TT Acetabular System) or bipolar heads. Clinical benefit derived from mechanical restoration of joint stability and mobility.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only. Mechanical testing included fatigue resistance (ISO 7206-4, ISO 7206-6), pull-out force evaluation, and burst strength testing for ceramic heads. Titanium plasma spray coating characterized per FDA guidelines.

Technological Characteristics

Monolithic Ti6Al4V stem (ASTM F1472/ISO 5832-3) with proximal plasma-sprayed titanium coating. 12/14 Morse taper connection. Biolox Delta ceramic femoral heads. Available in 9 sizes, standard/lateralized versions, 131°/134° CCD angles. Mechanical fixation via press-fit (uncemented).

Indications for Use

Indicated for skeletally mature patients requiring partial or total hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, hip dysplasia), rheumatoid arthritis, femoral head/neck fractures, or revisions with good remaining femoral bone stock.

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

• H-MAX S stems (Limacorporate, K112091)
• Encore Linear Hip (DJO, K972791 and K991325)
• Modulus Femoral Hip System (Limacorporate, K112158)
• Taperloc 12/14 Taper Femoral Component (BIOMET, K043537)
• Femoral Heads (Limacorporate, K112158)
• Articul/eze (DJO, K883460 and K980513)
• Biolox Delta Ceramic Femoral Heads (Zimmer, K130899)
• Biolox Delta Ceramic Femoral Heads (Smith & Nephew, K100412, K083762)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 6, 2014

Limacorporate S.p.A. % Stephen Peoples. VMD Peoples and Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K141327 Trade/Device Name: Minima S 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, KWY, KWZ, LPH, MBL Dated: June 11, 2014 Received: June 13, 2014

Dear Dr. Peoples:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Stephen Peoples

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Lori A. Wiggins

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

Enclosure

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510(k) Number (if known): K141327 Device Name: Minima S System Indications for Use:

# Minima S System Indications for Use

The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- · non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- rheumatoid arthritis;
- treatment of femoral head and neck fractures; .
- · revisions in cases of good remaining femoral bone stock.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

# Elizabeth D%rank -S

Division of Orthopedic Devices

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# Summary of Safety and Effectiveness

Date: July 16, 2014

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: [phone] FAX: [phone]

| Product | Common<br>Name | Product<br>Code | Regulation and Classification Name |
|--------------------|---------------------------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Minima S<br>System | Total or<br>Hemi<br>Hip<br>Prosthesis | LZO | Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous<br>uncemented prosthesis per 21 CFR<br>888.3353 |
| | | JDI | Hip joint metal/polymer semi-constrained<br>cemented prosthesis per 21 CFR<br>888.3350 |
| | | KWY | Hip joint femoral (hemi-hip)<br>metal/polymer cemented or uncemented<br>prosthesis per 21 CFR 888.3390 |
| | | KWZ | Hip joint metal/polymer constrained<br>cemented or uncemented prosthesis per<br>21 CFR 888.3310 |
| | | LPH | Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented<br>prosthesis per 21 CFR 888.3358 |
| | | MBL | Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented<br>prosthesis per 21 CFR 888.3358 |

#### Description:

The Minima S System is intended for partial or total hip arthroplasty in cementless use. It is a monolithic collarless stem available in 9 sizes (#4-#12) in standard and lateralized versions.

When used in total hip arthroplasty Minima S stems are coupled to:

- Biolox Delta femoral heads (object of this submission) or Limacorporate Femoral ● Heads (K112158) articulating with Limacorporate Cemented Cups (K112158) or
- Biolox Delta heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Delta TT Acetabular System (K112898).

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When used in partial hip arthroplasty the Minima S femoral stem is coupled to Lock Bipolar Heads (Limacorporate K112158).

The Minima S stem is made of Ti6Al4V and it has a plasma sprayed titanium coating in the proximal area (ASTM F1472 - ISO 5832-3). The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are lowered to reduce accidental contact between stem and acetabular cups and they are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.

The Minima S System stems is available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.

Biolox Delta Heads devices are used by surgeons to replace the head of the femur during total or partial hip surgery. They are characterized by a spherical shape and are coupled with the acetabular cup (K112158, K112898) inserted in the acetabulum, in total hip replacement, or with Lock Bipolar Heads (K112158) in partial hip replacement.

Biolox Delta heads are coupled with the Minima S stems by means of a 12/14 Morse taper. Biolox Delta heads are made of Biolox Delta ceramic and are available with 28, 32 and 36 mm of diameters and in sizes (offsets) S, M, L and XL (XL size available only for head size 36).

#### Intended Use:

The Minima S System stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S stems are intended for use with Lock Bipolar Heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- · non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- · rheumatoid arthritis;
- treatment of femoral head and neck fractures;
- · revisions in cases of good remaining femoral bone stock.

#### Predicate Devices:

For the Minima S Stem:

- H-MAX S stems (Limacorporate, K112091): ●
- Encore Linear Hip (DJO, K972791 and K991325); ●
- Modulus Femoral Hip System (Limacorporate, K112158); ●
- Taperloc 12/14 Taper Femoral Component (BIOMET, K043537). ●

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For the Biolox Delta Heads:

- Femoral Heads (Limacorporate, K112158):
- Articul/eze (DJO, K883460 and K980513); ●
- Biolox Delta Ceramic Femoral Heads (Zimmer, K130899); ●
- Biolox Delta Ceramic Femoral Heads (Smith & Nephew, K100412, K083762). ●

#### Comparable Features to Predicate Device(s):

The Minima S stems are similar to the predicate devices in terms of intended use, indications, design and materials. The Minima S stems can be used in total hip arthroplasty as all predicates and they can be used also in partial hip arthroplasty as the Modulus Femoral Hip System (K112158). All stems are intended for cementless use.

The Minima S stems has a design which is similar to predicates with the exception that Modulus stems are made of 2-pieces coupled through conical taper. Like predicates, the subject device is available in standard and lateralized versions, with different CCD angles, offsets and sizes.

The components of the Minima S stems are manufactured from the same materials as the predicate devices.

The same considerations can be done for the Biolox Delta Heads which are similar for intended use, design and materials to predicates

### Non-Clinical Testing:

The Minima S System was tested for fatigue resistance. Mechanical tests were performed on worst case components or constructs. The following tests were performed to demonstrate substancial equivalency of the Minima S System to predicate devices:

- Fatigue Test according to ISO 7206-6; ●
- Fatigue Tests according to ISO 7206-4 (at the end of the test the pull-out force for ceramic heads has been evaluated).

The tests results demonstrated the device's ability to perform under expected clinical conditions.

In addition the Titanium Plasma Spray coating has been characterized to verify the conformity to FDA guideline and referenced standards.

Biolox Delta heads have been tested for burst strength, fatigue and post-fatigue evaluation in accord to FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems. The tests results demonstrated the device's ability to perform under expected clinical conditions.

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## Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Minima
S System to the predicate devices.