Coupling of femoral modular heads with DELTA Acetabular System is indicated for use 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;
· Post-traumatic arthritis,
· Correction of functional deformity;
· Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
· Revisions in cases of good remaining bone stock.
· Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only)

The components are intended for use in cementless (press-fit) applications.

Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated 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;
· osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem);
· treatment of femoral head and neck fractures (Minima S and MasterSL stems)
· correction of functional deformity (MODULUS stems);
· revisions in cases of good remaining femoral bone stock.

The components are intended for use in cementless (press-fit) applications.

Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications.
Coupling of femoral modular heads with Cemented Cup is intended applications in hip arthroplasty where the acetabular socket needs reconstruction.

LimaCorporate Lock Bipolar femoral heads are intended to be used in Partial Hip replacement with compatible femoral components (Minima S, Master SL, C2, MODULUS femoral stems) for cementless applications.

This procedure is intended for redict of pain and/or improved hip function in skeletally mature patients with the following conditions: treatment of non-union, femoral neck fracture and intertrochanteric fractures unmanageable by other techniques.

Device Description

Biolox® Delta Revision heads consist of a Biolox® Delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the Biolox® Delta ceramic material (K141327, K182099) and come in various outer diameters. The ceramic Biolox® Delta ball head is assembled with the corresponding titanium sleeve and is then placed over the taper of an in-situ hip stem prosthesis, during revision of a previously implanted femoral head:

K170473, K112091, K160011, K140975, K151739, K161226, K141327, K143509, K150855

The titanium sleeve has an inner 12/14 taper which fits the dimensions of a metallic hip stem prosthesis, and the Biolox® Delta ball head has a 16/18 taper which fits to the dimensions of the outer diameter of the titanium sleeve. The ball head then articulates against an acetabular insert:

K112898, K141395, K182099, K181491, K191622, K200656

The titanium sleeves are available in sizes -3, 0, +4, and +7 (S, M, L, XL) and the ball heads of the Biolox® Delta Revision heads are available with outer diameters ranging from 28mm - 40 mm.

AI/ML Overview

Based on the provided text, the device in question is Biolox® Delta Revision heads, which are components of hip joint prostheses. The document is a 510(k) summary from the FDA, indicating a premarket notification for a medical device.

It's important to clarify that this document describes the substantial equivalence of a physical medical device (hip joint components), not a software-based or AI-driven diagnostic device. Therefore, the questions related to AI performance, ground truth establishment for AI, human reader improvement with AI assistance, and specific AI-related acceptance criteria are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to mechanical testing of the physical hip replacement components to demonstrate their performance and substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm's diagnostic accuracy.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not present performance in a typical "acceptance criteria vs. reported performance" table format for a diagnostic device. Instead, it states that "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."

The acceptance criteria are implied by the standards chosen for testing, and the performance is implicitly meeting those standards.

Acceptance Criteria (Implied by Test Standards)	Reported Device Performance
Ability to withstand burst forces (ISO 7206-10)	Fulfilled intended use & substantially equivalent to predicate
Resistance to fatigue failure (ISO 7206-10, ISO 7206-4, ISO 7206-6)	Fulfilled intended use & substantially equivalent to predicate
Resistance to pull-off forces (ISO 7206-10, ASTM F2009)	Fulfilled intended use & substantially equivalent to predicate
Resistance to fretting corrosion (ASTM F1875)	Fulfilled intended use & substantially equivalent to predicate
Resistance to torque-off (ISO 7206-13)	Fulfilled intended use & substantially equivalent to predicate

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

The document states, "Mechanical testing was performed on worst case components or constructs." It does not specify the exact number of samples tested (e.g., how many heads or constructs were subjected to each test). This is typical for mechanical testing where a representative "worst case" sample or a small batch is tested to ensure compliance with engineering standards.

Sample Size: Not explicitly stated as a number of units, but "worst case components or constructs."
Data Provenance: Not specified (e.g., country of origin). The mechanical testing is conducted by the manufacturer, Limacorporate S.p.A., based in Italy. The data is generated from laboratory testing of manufactured components, not patient data.
Retrospective or Prospective: Not applicable in the context of mechanical testing of physical devices.

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

This question is not applicable as the device is a physical hip implant component, not an AI or diagnostic software. Ground truth in this context would be related to material properties and mechanical integrity, established by engineering specifications and physical testing methods, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or clinical diagnoses, which is not relevant for mechanical testing of a medical device component. The "ground truth" for mechanical testing is derived from the physical properties and performance of the device under stress, measured by instruments according to established standards.

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

Not applicable. This device is a physical medical implant (hip replacement component), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This question refers to AI algorithm performance. The device is a physical hip implant component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering standards and specifications for mechanical integrity and durability. This is established by:

Physical measurements and material properties of the components.
Performance of the components when subjected to standardized mechanical loading (e.g., burst, fatigue, pull-off, fretting, torque-off tests) as defined by ISO and ASTM standards.
Comparison to the performance of legally marketed predicate devices, which have a history of safe and effective use.

8. The sample size for the training set

Not applicable. This question refers to machine learning. This device does not involve a training set for an AI algorithm.

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

Not applicable. As above, no AI "training set" is involved. The "ground truth" for the device's design and mechanical properties is based on established biomechanical and material science principles, engineering design standards, and the performance characteristics of previously cleared predicate devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol is a stylized representation of a human figure. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The words "FOOD & DRUG" are larger and bolder than the other words.

March 4, 2025

Limacorporate % Alessia Collarini Regulatory Affairs Specialist Enovis 9800 Metric Blvd. Austin, Texas 78758

Re: K243809

Trade/Device Name: Biolox® Delta Revision heads 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, LPH Dated: December 2, 2024 Received: December 11, 2024

Dear Alessia Collarini:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Limin Sùn -S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243809

Device Name Biolox® Delta Revision Heads

Indications for Use (Describe)

LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components.

Coupling of femoral modular heads with DELTA Acetabular System is indicated for use 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;
· Post-traumatic arthritis,
· Correction of functional deformity;
· Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
· Revisions in cases of good remaining bone stock.
· Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only)

The components are intended for use in cementless (press-fit) applications.

Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated 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;
· osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem);
· treatment of femoral head and neck fractures (Minima S and MasterSL stems)
· correction of functional deformity (MODULUS stems);
· revisions in cases of good remaining femoral bone stock.

The components are intended for use in cementless (press-fit) applications.

Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications.
Coupling of femoral modular heads with Cemented Cup is intended applications in hip arthroplasty where the acetabular socket needs reconstruction.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary K243809

Date prepared: February 6, 2025

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

U.S. Contact Person: Sherri Melligen sherri.mellingen@enovis.com Enovis 9800 Metric Blvd Austin, Texas 78758, USA www.enovis.com Cell Phone: 952-913-6383

Product	Product Code	Regulation and Classification Name
Biolox® Delta Revision heads	LZO	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353
Biolox® Delta Revision heads	LPH	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358

Common name: Femoral head with sleeve

Description:

K170473, K112091, K160011, K140975, K151739, K161226, K141327, K143509, K150855

K112898, K141395, K182099, K181491, K191622, K200656

The titanium sleeves are available in sizes -3, 0, +4, and +7 (S, M, L, XL) and the ball heads of the Biolox® Delta Revision heads are available with outer diameters ranging from 28mm - 40 mm.

Indications for Use:

LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components.

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Coupling of femoral modular heads with DELTA Acetabular System is indicated for use 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; • Post-traumatic arthritis, · Correction of functional deformity; · Fractures, dislocation of the hip and unsuccessful cup arthroplasty; · Revisions in cases of good remaining bone stock. • Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only) The components are intended for use in cementless (press-fit) applications. -Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated 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; · osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem); · treatment of femoral head and neck fractures (Minima S and MasterSL stems) · correction of functional deformity (MODULUS stems); · revisions in cases of good remaining femoral bone stock. The components are intended for use in cementless (press-fit) applications. -Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications. Coupling of femoral modular heads with Cemented Cup is intended for cemented applications in hip arthroplasty where the acetabular socket needs reconstruction. LimaCorporate Lock Bipolar femoral heads are intended to be used in Partial Hip replacement with compatible femoral components (Minima S, Master SL, C2, MODULUS femoral stems) for cementless applications. This procedure is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: treatment of non-union, femoral neck fracture and intertrochanteric fractures unmanageable by other techniques.

No.	Company	Device name	Clearedvia
-----	---------	-------------	----------------

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1 (Primary predicate)	TJO	Biolox Option Ceramic Heads Line	K213580
		Extension
2 (Additional predicate)	Biomet UK	Biolox® Delta Option Ceramic Heads	K192683
3 (Additional predicate)	Limacorporate	CoCrMo Femoral heads	K112158

Summary of technology comparison:

TJO Biolox® Option Ceramic Heads Line Extension and Biomet UK Biolox® Delta Option Ceramic Heads are provided with the same material, manufacturing, fixation, design, class, regulation number, and contain the same product codes. The mechanical testing for the subject device contains the equivalent testing to TJO Biolox® Option Ceramic Heads Line Extension.

The following stems have the same tapered design for the femoral heads: K170473, K112091, K160011, K140975, K151739, K161226, K141327, K143509, K150855.

Biolox Ceramic heads provided by Ceramtec are cleared with the following acetabular cups: K112898, K141395, K182099, K181491, K191622, K200656.

The design of the subject device uses the same dimensions of the LimaCorporate cleared 510(k) femoral heads. The fitment of the head uses a taper 12/14 press fit and the outer surface of the head to fit into the poly liner.

Non-clinical testing

Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices.

Mechanical testing was performed on worst case components or constructs:

Burst, fatigue, post fatigue, pull-off (ISO 7206-10)
Fretting corrosion test (ASTM F1875)
Pull-off test (ASTM F2009)
Torque-off test (ISO 7206-13)
Fatigue test (ISO 7206-4) mechanical evaluation ●
Fatigue-fretting test (ISO 7206-6) - mechanical evaluation

Conclusion

Based upon a comparison of intended use, materials, summary of technological characteristics, and non-Clinical testing, the Biolox® Delta Revision heads components are substantially equivalent to the predicate device components identified in this premarket notification.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

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