Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
For cemented and un-cemented use.

E1™ Acetabular Liners:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications (as based on mating shell)

Device Description

The device descriptions of the E1™ Tibial Bearings and the E1 ™ Acetabular Liners have not changed from the original predicate submissions.

AI/ML Overview

The provided 510(k) submission for the Biomet Manufacturing Corp.'s E1™ Antioxidant Infused Technology (E1™ Tibial Bearings and E1™ Acetabular Liners) does not contain information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML device evaluations.

This submission is for a medical device that is a physical implant (joint replacement components), not a software or AI/ML diagnostic tool. Therefore, the questions related to AI/ML specific performance metrics, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this document.

Here's a breakdown of the relevant information provided in the document:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission focuses on demonstrating substantial equivalence to predicate devices. This means the device must show it is as safe and effective as a legally marketed device.
Reported Device Performance:
- Non-Clinical Testing: "Further testing showed no decreases in the mechanical properties after accelerated aging." and "In contrast to the control materials, the E1™ hip and the E1™ knee materials showed no evidence of oxidation or oxidative degradation." This indicates that the E1™ technology performed robustly under accelerated aging conditions and resisted oxidation.
- Clinical Testing: "None provided." The submission explicitly states that no clinical testing was performed or provided for this 510(k) submission. This is common for devices seeking substantial equivalence where non-clinical data (e.g., mechanical testing, material characterization) is deemed sufficient.

2. Sample size used for the test set and the data provenance:

Not applicable. This device is a physical implant. The "test set" in this context refers to laboratory tests of the material, not a dataset of patient images or medical records. The document only mentions "further testing" without specifying sample sizes for mechanical properties or oxidation studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable.

4. Adjudication method 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:

No. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is not an AI/ML device.

7. The type of ground truth used:

Not applicable in the context of AI/ML ground truth. For this type of device, the "ground truth" for non-clinical testing is typically direct measurement of material properties and observation of degradation.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

In summary, the 510(k) submission for the E1™ Antioxidant Infused Technology relies on demonstrating substantial equivalence through non-clinical laboratory testing of the material's mechanical properties and resistance to oxidation, rather than clinical trials or AI/ML performance metrics.

Summary

{0}------------------------------------------------

K10004B

MAR - 9 2010

510(k) Summary

March 3, 2010 Date:

Biomet Manufacturing Corp. Applicant/Sponsor:

Contact Person: Becky Earl Regulatory Specialist

E1™ Antioxidant Infused Technology Proprietary Name: (E1™ previously known as E-Poly™)

Common or Usual Name: UHMWPE with antioxidant

Classification Name:

OIY-knee joint patellofemorotibial polymer/metal/polymer semi-. constrained cemented prosthesis (888.3560)
OQG-prosthesis, hip, semi-constrained, metal/polymer + additive, porous . uncemented (888.3358)
OQH-prosthesis, hip, semi-constrained, metal/polymer + additive, . cemented (888.3350)
OQI-prosthesis, hip, semi-constrained, metal/ceramic/polymer + additive, ● cemented or porous uncemented (888.3353)
JWH -cemented semi-constrained polymer/metal/polymer knee prosthesis . (888.3560)
LPH-prosthesis, hip, semi-constrained, metal/polymer, . Porous uncemented (888.3358);
JDI-prosthesis, hip, semi-constrained, metal/polymer, . Cemented (888.3350);
LWJ-prosthesis, hip, semi-constrained, metal/polymer, . Uncemented (888.3360);
MAY-prosthesis, hip, semi-constrained, metal/ceramic/ . Polymer, cemented or non-porous cemented, osteophilic finish (888.3353);
LZO-prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented . or non-porous, uncemented (888.3353)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate devices are the E-Poly™ Tibial Bearings, K080528, cleared June 17, 2008; E-Poly™ MaxRom™ Acetabular Liners, K070364, cleared May 3, 2007;

{1}------------------------------------------------

510(k) Summary E1™ Antioxidant Infused Technology Biomet Manufacturing Corp. Page 2

E-Poly™ (100kGy) Acetabular Liners-Additional Profiles, K070399, cleared May 4, 2007; Biolox® delta Ceramic Heads with 100 kGy E-Poly™ Acetabular Liners, K073102, cleared November 27, 2007; and 100kGy Acetabular Liners Additional Profiles: +3 MaxRom™ and +3 Hi-Wall, K090103, cleared February 11, 2009.

Device Description: The device descriptions of the E1™ Tibial Bearings and the E1 ™ Acetabular Liners have not changed from the original predicate submissions.

Indications For Use:

E1™ Tibial Bearings

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

E1™ Acetabular Liners

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
1. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications.

Summary of Technologies: The E1™Antioxidant Infused Technology is identical to that of the predicate devices.

Non-Clinical Testing: Further testing showed no decreases in the mechanical properties after accelerated aging. In contrast to the control materials, the E1™ hip and the E1™ knee materials showed no evidence of oxidation or oxidative degradation.

Clinical Testing: None provided

p. 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The stylized symbol on the right features three abstract human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

BioMet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K100048

Trade/Device Name: E1™ Tibial Bearings and E1TM Acetabular Liners Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: OIY, OQG, OQH, OQI, JWH, JDI, LZO, MAY, LPH, LWJ Dated: January 7, 2010 Received: January 8, 2010

MAR - 9 2010

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 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

{3}------------------------------------------------

Page 2 - Ms. Becky Earl

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Clavbare Buehm

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

Enclosure

{4}------------------------------------------------

Indications for Use

100048 510(k) Number (if known):

Device Name: E1™ Acetabular Liners

Indications for Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
1. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications (as based on mating shell)

Prescription Use _ YES (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)

Soutu
(Division Sign-Off)
for mxn

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K100048

{5}------------------------------------------------

Indications for Use

100048 510(k) Number (if known):

E1™ Tibial Bearings Device Name:

Indications for Use:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valqus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

For cemented and un-cemented use.

YES Prescription Use_ (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)

Qnita for mxn

(Division Signal Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100048

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.