NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis or traumatic arthritis
Correction of functional deformity
Non-union femoral neck fracture
Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Device Description

The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.

The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The unipolar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.

The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.

The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NovoHip Total Hip System:

Summary of Acceptance Criteria and Study Findings

The NovoHip Total Hip System's acceptance criteria are based on its ability to perform comparably to predicate devices through a series of non-clinical mechanical tests. The study demonstrates that all tested components met their required performance specifications, thereby establishing substantial equivalence to existing marketed hip prostheses.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength & Durability	Fatigue Performance Test for NovoHip Stem	Meet required performance specifications for fatigue	Met required performance specifications
	Fatigue Performance Test for the Neck Portion of the NovoHip Stem	Meet required performance specifications for fatigue	Met required performance specifications
	Burst Strength Test for NovoHip Ceramic Femoral Heads (Static Compression)	Meet required performance specifications for static burst strength	Met required performance specifications
	Cyclic Fatigue Test for NovoHip Ceramic Femoral Heads (Cyclic Compression)	Meet required performance specifications for cyclic fatigue	Met required performance specifications
	Post-Cyclic Fatigue Burst Test for NovoHip Ceramic Femoral Heads (Static Compression)	Meet required performance specifications for post-cyclic burst strength	Met required performance specifications
Interface Stability & Integrity	Disassembly Force Test for the NovoHip Neck Taper/Femoral Head Interface	Meet required performance specifications for interface disassembly force	Met required performance specifications
	Pull-Off Test for NovoHip Ceramic Femoral Heads	Meet required performance specifications for pull-off strength	Met required performance specifications
	Rotational Stability Test for NovoHip Ceramic Femoral Heads	Meet required performance specifications for rotational stability	Met required performance specifications
	Lever-Out Test for NovoHip Acetabular Shell/Liner Assembly	Meet required performance specifications for lever-out resistance	Met required performance specifications
	Torque-Out Test for NovoHip Acetabular Shell/Liner Assembly	Meet required performance specifications for torque-out resistance	Met required performance specifications
	Push-In Test for NovoHip Acetabular Shell/Liner Assembly	Meet required performance specifications for push-in force	Met required performance specifications
	Push-Out Test for NovoHip Acetabular Shell/Liner Assembly	Meet required performance specifications for push-out force	Met required performance specifications
Anatomical & Functional	Range of Motion Test for the NovoHip Total Hip System	Meet required performance specifications for range of motion	Met required performance specifications
Bone Screw Performance (if applicable)	Torsional Properties Test for NovoHip Bone Screws	Meet required performance specifications for torsional strength	Met required performance specifications
	Driving Torque Test for NovoHip Bone Screws	Meet required performance specifications for driving torque	Met required performance specifications
	Axial Pull-Out Strength Test for NovoHip Bone Screws	Meet required performance specifications for axial pull-out strength	Met required performance specifications

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the non-clinical tests. The data provenance is non-clinical laboratory testing, likely conducted by or for the manufacturer (NovoSource, Inc.), and is retrospective in the sense that it evaluates the device's characteristics against predefined specifications rather than observing its performance over time in a living system. The country of origin for the data is implied to be within the US, given the submission to the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of submission. The ground truth for mechanical testing is established by engineering standards and predefined performance specifications derived from regulatory guidelines and predicate device performance, not by expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective mechanical performance evaluations against defined specifications, there is no need for expert adjudication. The result is either "meets specification" or "does not meet specification."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The NovoHip Total Hip System is a mechanical implant, and its performance is evaluated through objective physical and mechanical testing.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical hip implant, not an algorithm or software. The "standalone" performance here refers to the device's mechanical integrity as tested in a laboratory setting. All listed tests are "standalone" in this physical sense, meaning the device's performance was evaluated independently without human surgical interaction during the test itself (though humans designed and conducted the tests).

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests used in this submission is based on:

Engineering Standards and Specifications: Performance requirements derived from nationally and internationally recognized standards (e.g., ISO, ASTM for medical devices) for hip implants and their components.
Predicate Device Performance: The performance characteristics of the legally marketed predicate devices (Stelkast Provident Hip System, Smith & Nephew Biolox Delta Ceramic Femoral Head, Wright Medical Lineage Acetabular System) serve as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device because it is a physical medical implant, not an AI or machine learning model that requires training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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510(k) Summary

FEB 2 1 2014

Applicant/Sponsor:

NovoSource, Inc. 714 East Monument Ave. Suite 220 Dayton, OH, 45402 937-531-6591

Contact Person:

Sharon Kvistad Navigant Consulting, LLC 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 317-228-8715 sharon.kvistad@navigant.com

Date of Preparation: February 18, 2014 .

NAME AND CLASSIFICATION

Proposed Trade Name:	NovoHip Total Hip System
Common Name:	Hip prosthesis
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis per 21 CFR 888.3358
	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis per 21 CFR 888.3353
Device Product Code:	LPH, LZO
Predicate Devices:	Stelkast Provident Hip System (K935484, K033944)Smith & Nephew Biolox Delta Ceramic Femoral Head (K083762)Wright Medical Lineage Acetabular System (K002149)
Device Classification:	Class II

DEVICE DESCRIPTION

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K132158 page 2/3

The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The unipolar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.

The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.

INTENDED USE

Hip joint arthroplasty

INDICATIONS FOR USE

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis or traumatic arthritis
· Correction of functional deformity
· Non-union femoral neck fracture
Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

TECHNOLOGICAL CHARACTERISTICS

The NovoHip Total Hip System has the same intended use as the predicate devices. The NovoHip Total Hip System has similar indications for use as the as the predicate devices. The NovoHip Total Hip System is manufactured from the same materials as the predicate devices. The range of sizes of the NovoHip Total Hip System is similar to the predicate devices.

SUMMARY OF STUDIES

Non-Clinical Testing

The NovoHip Total Hip System underwent the following testing:

Fatigue Performance Test for NovoHip Stem .
Fatigue Performance Test for the Neck Portion of the NovoHip Stem ●
. Disassembly Force Test for the NovoHip Neck Taper/Femoral Head Interface
. Range of Motion Test for the NovoHip Total Hip System

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. Burst Strength Test for NovoHip Ceramic Femoral Heads (Static Compression)
. Cyclic Fatigue Test for NovoHip Ceramic Femoral Heads (Cyclic Compression)
Post-Cyclic Fatigue Burst Test for NovoHip Ceramic Femoral Heads (Static Compression) .
. Pull-Off Test for NovoHip Ceramic Femoral Heads
. Rotational Stability Test for NovoHip Ceramic Femoral Heads
. Torsional Properties Test for NovoHip Bone Screws
. Driving Torque Test for NovoHip Bone Screws
. Axial Pull-Out Strength Test for NovoHip Bone Screws
. Lever-Out Test for NovoHip Acetabular Shell/Liner Assembly
Torque-Out Test for NovoHip Acetabular Shell/Liner Assembly .
. Push-In Test for NovoHip Acetabular Shell/Liner Assembly
. Push-Out Test for NovoHip Acetabular Shell/Liner Assembly

All devices met the required performance specifications for testing and are considered equivalent to the predicate devices.

Clinical Testing

No clinical testing was required.

CONCLUSION

Based on testing results and the comparisons provided, the NovoHip Total Hip System is considered substantially equivalent to the Stelkast Provident Hip System and the Wright Medical Lineage in material, construction and performance characteristics.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

February 21, 2014

Novosource, Incorporated % Ms. Sharon Kvistad Associate Director Navigant Consulting, LLC 9001 Wesleyan Road, Suite 200 Indianapolis, Indiana 46268

Re: K132158

Trade/Device Name: NovoHip Total Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO Dated: January 13, 2014 Received: January 14, 2014

Dear Ms. Kvistad:

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

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Page 2 - Ms. Sharon Kvistad

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Vincent Dogylin -S

for

Mark N. Melkerson 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): K132158

Device Name: NovoHip Total Hip System

Indications for Use:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis
Rheumatoid arthritis or traumatic arthritis .
Correction of functional deformity .
. Non-union femoral neck fracture
Trochanteric fractures of the proximal femur with head involvement which is . unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a falled total hip arthroplasty.

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

Elizabet标办公Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
Classification. Class II.