Noninflammatory 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; and
Revision procedures where other treatment or devices have failed.

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.

Device Description

The Renovis Surgical Technologies, Inc. A400 Surgical Hip Replacement System (Renovis A400 Hip System) is a family of components designed in a variety of standard clinically usable sizes for cementless total hip replacements (i.e. replacements where both the femur and acetabulum are replaced).

The system consists of four main components available in a variety of clinically usable sizes.

A) Femoral Stem (titanium alloy)

B) Femoral Head (CoCr and Biolox delta ceramic)

C) Acetabular Cup (titanium alloy)

D) Acetabular Liners (Mechanically annealed HXL polyethylene with and without alphatocopherol)

The Renovis A400 Hip System implant components are provided sterile and are for single use.

AI/ML Overview

The provided text describes a 510(k) submission for the RENOVIS A400 Surgical Hip Replacement System. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comprehensive performance testing, rather than reporting on a study to meet pre-defined acceptance criteria with device performance results in a standalone clinical setting.

Therefore, many of the requested elements for acceptance criteria, device performance, and study details like sample size for test sets, expert involvement for ground truth, and comparative effectiveness studies are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance results in the format typically seen for a new clinical study with pre-defined metrics. Instead, the "Performance Testing" section lists various tests performed to demonstrate safety, efficacy, and substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Renovis A400 Hip System's performance meets the standards or guidance documents referenced (e.g., ISO, ASTM, FDA Guidance) and is comparable to the predicate devices, thereby raising no new questions of safety or effectiveness.

Test Category & Standard	Implicit Acceptance Criteria	Reported Device Performance	Comments
A400 Hip System Tests			All tests reported to demonstrate system is "safe for its intended uses and is substantially equivalent to the predicate devices."
Distal Stem Fatigue (ISO 7206-4:2002)	Meets or exceeds ISO standard for fatigue life.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Proximal Stem Fatigue (ISO 7206-6:1992)	Meets or exceeds ISO standard for fatigue life.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Push-out Snap-Lock (ASTM F1820-97)	Meets ASTM standard for liner retention.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Lever-out and Torque-out Snap-Lock	Meets internal standards/comparable to predicates.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
CoCr Head Attachment (ISO 7206-10:2003)	Meets ISO standard for head attachment strength.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
BIOLOX delta Ceramic Heads Attachment (FDA Guidance)	Meets FDA Guidance for ceramic head attachment.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Range of Motion Analysis	Demonstrates appropriate range of motion.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Hip Simulator Wear Testing (ISO 14242-1)	Meets ISO standard for wear rates under normal conditions.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Hip Simulator Wear Testing (Abrasive Wear)	Meets ISO standard for wear rates under abrasive conditions.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Wear Debris Characterization (ASTM F1877-05)	Meets ASTM standard for debris characterization.	Not explicitly quantified, but met requirement for substantial equivalence.	Bench testing.
Porous Surface/Coating Tests			All tests reported to "evaluate the integrity of the porous surface/coating" and implicitly met for substantial equivalence.
Abrasion resistance (ASTM F1978)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Shear fatigue strength (ASTM F1160)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Static shear strength (ASTM F1044)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Static tensile strength (ASTM F1147)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Characterization (ASTM F1854)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Acetabular Liner (Poly) Char. Tests			All poly characterization test results "demonstrate that the A400 Hip System design is safe for its intended use and is substantially equivalent to the predicate devices."
Heat of fusion, melting point, % crystallinity (ASTM F2625/D3418)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Small punch test properties (ASTM F2183)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Oxidation measurement (ASTM F2102)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Trans-vinylene yield (ASTM F2381)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Crosslink density (ASTM F2214)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Tensile properties (ASTM D638)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Izod impact strength (ASTM D256 / F648)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
GCMS and LCMS extract analyses	Demonstrates material purity and absence of harmful leachables.	Not explicitly quantified.	Bench testing.
Vitamin E content	Verified as specified.	Not explicitly quantified.	Bench testing.
Fatigue crack propagation (ASTM E647)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Compressive modulus (ASTM D695)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Uniformity of radiation dose	Verified as specified.	Not explicitly quantified.	Bench testing.
Free radical content (Electron Spin Res.)	Verified as specified.	Not explicitly quantified.	Bench testing.
Consolidation verification	Verified as specified.	Not explicitly quantified.	Bench testing.
Density (ASTM D1505/D792)	Meets ASTM standard.	Not explicitly quantified.	Bench testing.
Polyethylene Biocompatibility Tests (ISO 10993)			All tests performed to demonstrate biocompatibility and implicitly met for substantial equivalence.
Systemic Toxicity (Rabbit Pyrogen Test)	Meets ISO 10993 standard for absence of pyrogenic reaction.	Not explicitly quantified.	In-vivo testing.
Systemic Toxicity (Acute Systemic Toxicity)	Meets ISO 10993 standard for absence of acute systemic toxicity.	Not explicitly quantified.	In-vivo testing.
In Vitro Cytotoxicity Study (ISO Elution)	Meets ISO 10993 standard for absence of cytotoxicity.	Not explicitly quantified.	In-vitro testing.
Genotoxicity (Chromosomal Aberration)	Meets ISO 10993 standard for absence of genotoxicity.	Not explicitly quantified.	In-vitro/in-vivo testing.
Genotoxicity (Mouse Micronucleus Assay)	Meets ISO 10993 standard for absence of genotoxicity.	Not explicitly quantified.	In-vivo testing.
Genotoxicity (Bacterial Reverse Mutation)	Meets ISO 10993 standard for absence of genotoxicity.	Not explicitly quantified.	In-vitro testing.
Irritation/Skin Sensitization (Intracutaneous Study)	Meets ISO 10993 standard for absence of irritation/sensitization.	Not explicitly quantified.	In-vivo testing.
ISO Muscle Implantation (Rabbits - 2 Weeks)	Meets ISO 10993 standard for tissue compatibility.	Not explicitly quantified.	In-vivo testing.
ISO Muscle Implantation (Rabbits - 13 Weeks)	Meets ISO 10993 standard for tissue compatibility.	Not explicitly quantified.	In-vivo testing.
Irritation/Skin Sensitization (Guinea Pig)	Meets ISO 10993 standard for absence of irritation/sensitization.	Not explicitly quantified.	In-vivo testing.
Systemic Toxicity (Sub-Chronic IV)	Meets ISO 10993 standard for absence of sub-chronic toxicity.	Not explicitly quantified.	In-vivo testing.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the document. The document refers to "comprehensive bench performance testing" and "the following device tests were performed," implying specific quantities of components were tested for each standard. For example, fatigue testing would involve multiple samples, but the exact number is not provided.
- Data Provenance: The tests are benchtop "performance testing" and in-vitro/in-vivo biocompatibility testing, not human-patient data. The document does not specify the country of origin for the actual testing, but the submission is to the U.S. FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a mechanical and biocompatibility testing submission for a hip implant, not an AI or diagnostic device requiring expert consensus for a "ground truth" on patient data. The "ground truth" for these tests is defined by the technical specifications and performance criteria within the referenced ISO, ASTM, and FDA guidance documents.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This type of adjudication is typically used for clinical study endpoints or image interpretation, not for standard bench and biocompatibility testing results. The results of these tests (e.g., fatigue life, wear rate, toxicity) are objectively measured against established standards.
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. An MRMC study is completely irrelevant for this 510(k) submission, which concerns a physical hip implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a surgical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the established international and national standards (ISO, ASTM, FDA Guidance) for mechanical properties, wear characteristics, and biocompatibility of orthopedic implants. The device's performance is compared against these engineering and biological benchmarks, and against the known characteristics of the predicate devices.
The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; there is no "training set" in the conventional sense. The "training" for the design might refer to iterative design and testing, but no formal training set size is mentioned.
How the ground truth for the training set was established
- Not Applicable. See point 7.

Summary

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RENOVIS

RENOVIS Surgical Technologies, Inc.

510(k)# K112897

510(k) Summary

Submitter's Name: Renovis Surgical Technologies, Inc.
Address: 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374
Contact Person: Anthony DeBenedictis Vice President of Quality Assurance Phone: 909.557.2360

Date Prepared: May 31, 2012

Classification Name:	Prosthesis, Hip Revision System
Common Name:	Surgical Hip Joint Replacement System
Model Number:	A400
Product Code:	OQG, OQI, LPH, LZO
C.F.R. Section:	888.3353-Hip joint
	metal/ceramic/polymer semi-constrained
	cemented or nonporous uncementedprosthesis.
	888.3358-Hip joint
	metal/polymer/

metal semi-constrained porouscoated uncemented prosthesis.

Recommended Classification: ......................................	Class II
Classification Panel: ......................................	Orthopedics
Reason for Submission: ......................................	Traditional 510(k)

Device Description:

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Image /page/1/Picture/0 description: The image shows the text 'K112897' at the top. Below that is the word 'RENOVIS' in large, bold, sans-serif font. To the left of the word 'RENOVIS' is a circular graphic with three overlapping shapes.

The system consists of four main components available in a variety of clinically usable sizes.

A) Femoral Stem (titanium alloy)

B) Femoral Head (CoCr and Biolox delta ceramic)

C) Acetabular Cup (titanium alloy)

D) Acetabular Liners (Mechanically annealed HXL polyethylene with and without alphatocopherol)

The Renovis A400 Hip System implant components are provided sterile and are for single use.

Indications for Use

The Renovis A400 Surgical Hip Replacement System is indicated for patients suffering from:

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; and
Revision procedures where other treatment or devices have failed.

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.

Predicate Devices

Predicate List

510(k) Number	Manufacturer
K030055	Biomet Manufacturing
K032396	Biomet Manufacturing
K051411	Biomet Manufacturing
K061312	Biomet Manufacturing
K070364	Biomet Manufacturing
K073102	Biomet Manufacturing

2 Page

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×112897

RENOVIS

K091956	DJO Surgical
K094035	StelKast, Inc.
K043537	Biomet Manufacturing
K093235	Biomet Manufacturing
K981211	Sulzer Orthopedics

Substantial Equivalence

The Renovis A400 Surgical Hip Replacement System claims substantial equivalence to commercially available hip prosthesis systems and related hip system components manufactured by Biomet Manufacturing Corporation (Biomet).

The Renovis A400 Hip System's intended use and indications for use are identical to the Biomet hip prosthesis system and associated components.

The Renovis A400 Hip System implanted components: femoral head; acetabular cup; acetabular liners, with vitamin E and without vitamin E are equivalent and raise no new question of safety or technology to those devices manufactured by Biomet. The materials used for all Renovis A400 Hip System components are similar to those used in the components of the Biomet hip prosthesis system predicate devices. All materials used in the Renovis A400 Surgical Hip Replacement System are biocompatible and are well known and commonly used in the orthopedic implant industry.

Performance Testing

Comprehensive bench performance testing conducted on the hip system components: femoral stems, femoral heads, and acetabular liners demonstrated that the A400 Hip System design is safe for its intended use and is substantially equivalent to the predicate devices. The following bench/ performance testing was conducted on the A400 Hip System:

A) A400 Hip System – The following device tests were performed on the complete A400 Hip system and demonstrate the system is safe for its intended uses and is substantially equivalent to the predicate devices:

Distal Stem Fatigue Testing per ISO 7206-4:2002/ Guidance for Industry and FDA 1. Staff - Non-clinical Information for Femoral Stem Prostheses, September 1997
Proximal Stem Fatigue Testing per ISO 7206-6:1992/ Guidance for Industry and FDA 2. Staff – Non-clinical Information for Femoral Stem Prostheses, September 1997
Push-out Snap-Lock Testing of Acetabular Liners and Shells per ASTM F1820-97 3.

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K"2897

RENOVIS

Lever-out and Torque-out Snap-Lock Testing of Acetabular Liners and Shells 4.
1. CoCr Head Attachment Testing per ISO 7206-10:2003
BIOLOX delta Ceramic Heads Attachment Testing per FDA Guidance Document for 6. the Preparation of Premarket Notifications for Ceramic Ball Hip Systems
Range of Motion Analysis 7..
Hip Simulator Wear Testing under Normal Conditions per ISO 14242-1 8.
Hip Simulator Wear Testing under Abrasive Wear Conditions per ISO 14242-1 ക്
Wear Debris Characterization per ASTM F1877-05 10.

B) Femoral Stem and Acetabular Cup Porous Surface/Coating- the following tests were performed to evaluate the integrity of the porous surface/coating:

1. Abrasion resistance per ASTM F1978
1. Shear fatigue strength per ASTM F1160
1. Static shear strength per ASTM F1044
1. Static tensile strength per ASTM F1147
1. Characterization per ASTM F1854

C) Acetabular Liner – The following poly characterization testing, both chemical and mechanical, was performed on the HXL polyethylene materials:

1. Heat of fusion , melting point, and percent crystallinity per ASTM F2625/D3418
1. Small punch test properties (peak load, ultimate load, ultimate displacement, work to failure) per ASTM F2183
1. Oxidation measurement per ASTM F2102
1. Trans-vinylene vield per ASTM F2381
1. Crosslink density (Swell Ratio Testing) per ASTM F2214
1. Tensile properties (yield strength, ultimate strength, elongation at break, elastic modulus) per ASTM D638
1. Izod impact strength per ASTM D256 /F648
1. GCMS and LCMS extract analyses
1. Vitamin E content
1. Fatigue crack propagation per ASTM E647
1. Compressive modulus per ASTM D695
1. Uniformity of radiation dose
1. Free radical content (Electron Spin Resonance)
1. Consolidation verification
1. Density per ASTM D1505/D792

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K112897

SRENOVIS

All poly characterization test results demonstrate that the A400 Hip System design is safe for its intended use and is substantially equivalent to the predicate devices.

D) Polyethylene Biocompatibility - The following tests in accordance with ISO 10993 (permanent implant panel) were performed on the polyethylene material to demonstrate biocompatibility:

1. Systemic Toxicity: Materials Mediated Rabbit Pyrogen Test per ISO 10993-11 and -12
1. Systemic Toxicity: Acute Systemic Toxicity per ISO 10993-11 and -12
1. In Vitro Cytotoxicity Study Using the ISO Elution Method per ISO 10993-5
1. Genotoxicity: Chromosomal Aberration per ISO 10993-1, -3,-5, and -12.
1. Genotoxicity: In-Vivo Mouse Micronucleus Assay per ISO 10993-3 and -12
1. Genotoxicity: Bacterial Reverse Mutation per ISO 10993-3.
1. Irritation and Skin Sensitization: Intracutaneous Study per ISO 10993-2 and -10.
1. ISO Muscle Implantation Study in Rabbits- 2 Weeks per ISO 10993-2 and -6
1. ISO Muscle Implantation Study in Rabbits- 13 Weeks per ISO 10993-2 and -6
1. Irritation and Skin Sensitization: Guinea Pig Maximization Sensitization Test per ISO 10993-2 and -10
1. Systemic Toxicity: Sub-Chronic (14 Day) Intravenous Toxicity Study per ISO 10993-11 and -12

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

JUN 1 3 2012

Renovis Surgical Technologies, LLC c/o David Teicher, DuVal & Associates 825 Nicollet Mall Minneapolis, Minnesota 55402

Re: K112897

Trade/Device Name: Renovis A400 Hip Joint Replacement Prosthesis 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: OQG, OQI, LPH, LZO Dated: May 4, 2012 Received: May 7, 2012

Dear Mr. Teicher:

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

{6}------------------------------------------------

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

Sincerely yours,

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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X112897

RENOVIS Surgical Technologies, Inc.

Indications for Use

510(k) Number (if known): K112897

Device Name: Renovis A400 Surgical Hip Joint Replacement Prosthesis

Indications for Use:

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is indicated for patients suffering from the following:

Noninflammatory 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; and 5. Revision procedures where other treatment or devices have failed.

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

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

510(k) Number K112.897

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.