TAPERLOC COMPLETE SIZE 4MM AND XR 123

K120030 · Biomet Manufacturing Corp · LPH · Aug 17, 2012 · Orthopedic

Device Facts

• Record ID: K120030
• Device Name: TAPERLOC COMPLETE SIZE 4MM AND XR 123
• Applicant: Biomet Manufacturing Corp
• Product Code: LPH · Orthopedic
• Decision Date: Aug 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Porous coated components are intended for uncemented biological fixation.

Device Story

Taperloc® Complete Size 4mm and XR 123° are uncemented porous modular hip prostheses. These devices are line extensions of the Taperloc® Complete system. The 4mm stems provide a smaller size option for full-length and Microplasty profiles. The XR 123° stems feature a modified 123° neck angle to reduce vertical offset (leg length) while maximizing horizontal offset. The devices are implanted by orthopedic surgeons during hip arthroplasty procedures. The prosthesis replaces the femoral head and neck, providing biological fixation via a plasma-sprayed porous coating. The surgeon selects the appropriate stem size and offset to restore joint mechanics and stability. The device benefits patients by addressing degenerative joint disease, fractures, or failed prior implants, aiming to restore function and reduce pain.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including proximal and distal pot fatigue testing on worst-case configurations determined by Finite Element Analysis (FEA). Testing met acceptance criteria per ASTM F2068-03 and ASTM 1612-95 (Reapproved 2005).

Technological Characteristics

Uncemented modular hip prosthesis. Features include trapezoidal neck design, short taper, 133° or 123° neck angle, and plasma-sprayed porous coating for biological fixation. Materials and surface finish (fine sisal buff) are identical to predicates. Mechanical testing performed per ASTM F2068-03 and ASTM 1612-95. No software or electronic components.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric with head involvement) unmanageable by other techniques, and revision procedures where other treatments failed.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Taperloc® Complete Stems (K101086)
• Taperloc® Complete, Sizes 5mm and 6mm (K103755)
• Taperloc® Complete Microplasty Stems (K110400)

Submission Summary (Full Text)

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/20030

Pge 1/4

AUG 1 7 2012

Image /page/0/Picture/3 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized, blocky font with a registered trademark symbol to the right. Below the logo, the words "MANUFACTURING CORP" are printed in a simpler, sans-serif font.

### 510(k) Summary

Preparation Date:

### August 14, 2012

Applicant/Sponsor:

Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment Registration Number: 1825034

Contact Person:

Becky Earl Regulatory Specialist

· Proprietary Name:

Common Name:

Classification Name:

Taperloc® Complete Size 4mm and XR 123

Uncemented porous modular hip prosthesis

LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · (21 CFR 888.3358)

LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888.3353)

KWZ-Prosthesis; Hip, Constrained, Cemented or Uncemented, Metal/Polymer (21 CFR 888.3310)

JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)

KWY-Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented (21 CFR 888.3390)

MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353)

KWL-Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis (21 CFR 888.3360)

OQG-Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (888.3358)

Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800,348,9500 Office: 574.267.6639 Main Fax: [phone] ww.biomet.com

Shipping Address: 56 East Bell Drive Warsaw, IN 46582

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# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Taperloc® Complete Stems-Biomet-(K101086) Taperloc® Complete, Sizes 5mm and 6mm-Biomet—(K103755) Taperloc® Complete Microplasty Stems-Biomet-(K110400)

### Device Description:

### Taperloc® Complete Size 4mm Stems

The Taperloc® Complete Size 4mm stems will combine the design features of the Taperloc® Complete fulllength stems (K101086 and K103755) and the shortened design of the new Taperloc® Complete Microplasty, K110400. This submission is extending the implant size range to 4mm for the Full Profile (full-length and Microplasty), the Reduced Distal Profile (full-length and Microplasty), and the Traditional Reduced Distal Profile (full-length only). The design characteristics of the size 4mm full-length stems and Microplasty stems are identical to the Taperloc® Complete implants (K101086, K103755 and K110400); this is simply a line extension of our current offerings. These characteristics include: trapezoidal neck design, short taper, 133° neck angle, same material properties of the stem and plasma spray, a reduced profile distal stem, and an updated insertion/extraction hole.

### Taperloc® Complete XR 123° Stems

The Taperloc® Complete XR 123° implants incorporate all the benefits of the Taperloc® Complete system, both full-length and Microplasty, as mentioned above, with a single offset neck option for the Full Profile and the Reduced Distal Profile. The only change is the 123° offset option, which was developed to reduce vertical offset (leg length), while maximizing horizontal offset. This option is supported through additional mechanical testing.

#### Intended Use:

Porous coated components are intended for uncemented biological fixation.

#### Indications for Use:

- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
- Rheumatoid arthritis 2.
- Correction of functional deformity 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. head involvement, unmanageable by other techniques.
- ട. Revision procedures where other treatment or devices have failed.

Porous coated components are intended for uncemented biological fixation.

# Summary of Technologies:

- The technological characteristics are the same as the predicates identified in the Legally Marketed . Devices to which substantial equivalence is claimed. The intramedullary plasma sprayed region of the

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Taperloc® Complete Size 4mm stems and the XR 123° stems have remained unchanged from the predicate Biomet Taperloc® Complete Stems (K101086, K103755, and K110400). The trunnion for the XR 123° has been modified to include a reduced neck angle of 123°, as compared to 133° of the predicate Taperloc® Complete Stems (K101086, K103755 and K110400). The trapezoidal design, taper junction and fine sisal buff surface finish of the Taperloc® Complete 4mm and the XR 123° stems are the exact same used with the predicate Biomet Taperloc® Complete Stems (K101086, K103755 and K110400). Additionally, the updated insertion/extraction hole is identical to the Taperloc® Complete stem predicates (K101086, K103755 and K110400). Stem lengths are within the range of the legally marketed predicates.

### Non-Clinical Testing:

## Taperloc_4mm 133"

### MT6461-Taperloc Complete 4mm 133° Proximal Pot Fatigue Test

The proximal pot test was conducted on the 4mm High Offset Taperloc® Complete Microplasty Stems that included the new design modifications, determined to be worst case by Finite Element Analysis (FEA). Six stems, combined with +12 modular heads, were tested and passed the 10 million cycles to 120lbs. The results meet the acceptance criteria set forth by ASTM F2068-03. Since the worst-case 4mm 133° High Offset passed the mechanical test, it can be expected that the 4mm 133° Standard Offset implant will also pass this proximal pot mechanical test.

# MT6540-Taperloc Complete 4mm 133° Distal Pot Fatigue Test

Six 4mm 133° Standard Offset Microplasty Stems represented the worst-case, as determined by FEA, simulating the distal pot loading scenario. (The worst-case stress conditions were shown in the High Offset stems, but since the High Offset stems are not included in this submission, the second worst stem, the 4mm 133 Standard Offset was tested.) All six stems tested passed 5 million cycles to

67lbs - 517lbs, meeting acceptance criteria as set forth in FDA guidance.

### Taperloc Complete XR 123°

# MT6579—Taperloc Complete XR 123° Proximal Pot Fatigue Test

Based on the FEA results of the twelve smallest stem sizes, as expected, the smallest stem was the worst-case. FEA showed that both Full-Length sizes and Microplasty sizes were found to perform the same, because the only differences between the two are their distal geometries which are potted deep in the potting media and have no effect on the strength of the proximal geometry. Therefore, six, of the 4mm XR 123° Microplasty stems, combined with +12 modular heads were tested. All six stems passed 10 million cycles to 120lbs -1,200lbs. These results meet the acceptance criteria set forth by ASTM F2068-03, and it can be said that the entire Taperloc Complete XR 123° hip system will withstand the same loading conditions.

### MT6609—Taperloc Complete XR 123° Distal Pot Fatigue Test

As determined by FEA, the worst-case stem is the combination of the smallest diameter stem (4mm) with a large horizontal offset and low vertical offset, combined with a femoral head that has the highest available offset (28mm +12). The XR 123° worst-case stem was potted at the same level as the other Taperloc Complete stems (K101086, K103755, K110400) relative to the intersection of the medial curve and resection level. The first round of testing encountered some issues due to potting media breakdown. After this problem was corrected, six samples withstood the loading for 5,000,000 cycles. Upon the completion of the test, the stems were found to be in their original condition. All six stems tested 5 million cycles to 67lbs - 517lbs, meeting acceptance criteria as set forth ASTM 1612-95 (Reapproved 2005).

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# Clinical Testing:

None provided as a basis for substantial equivalence.

.

The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

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

AUG 1 7 2012

Biomet Manufacturing Corporation % Ms. Becky Earl Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K120030

Trade/Device Name: Taperloc® Complete Size 4mm and XR 123° Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, KWZ, JDI, KWY, MEH, KWL, OQG Dated: July 13, 2012 Received: July 16, 2012

Dear Ms. Earl:

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

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# Page 2 - Ms. Becky Earl

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 forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours;

Eunice Keith

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

Enclosure

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# Page 1 of 1

# Indications for Use

K/20030 510(k) Number (if known):

Device Name: Taperloc Complete Size 4mm and XR 123°

Indications For Use:

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- Correction of functional deformity. 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal ব femur with head involvement, unmanageable by other techniques.
- 5. Revision procedures where other treatment or devices have failed.

Porous coated components are intended for uncemented biological fixation.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anishb

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120030