(83 days)
Not Found
No
The document describes a mechanical implant (femoral modular heads) and its intended use and mechanical testing. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is a component of a total hip arthroplasty system, which is a medical procedure aimed at reducing pain and improving hip function in patients with various conditions such as degenerative joint disease, arthritis, and fractures. These are therapeutic indications as they address and treat specific medical conditions, leading to improved patient health and well-being.
No
Explanation: The device is a femoral modular head used in hip arthroplasty to replace or revise portions of the hip joint. Its purpose is to treat various degenerative and traumatic conditions of the hip, not to diagnose them.
No
The device description clearly describes physical components (Biolox® Delta ball head and a titanium sleeve) intended for surgical implantation. It also details mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a component for Total Hip arthroplasty and Partial Hip replacement. These are surgical procedures performed in vivo (within the body) to replace or repair a joint.
- Device Description: The device description details the physical components (ball head, titanium sleeve) and how they are assembled and used within the hip joint. This is consistent with an implantable medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the LimaCorporate Femoral modular heads and Lock Bipolar femoral heads are medical devices, specifically implantable orthopedic devices, and not IVDs.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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
3
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.
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.
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.
4
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5
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:
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.
Indications for Use:
LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components.
6
- 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 | Cleared
via |
| ----- | --------- | ------------- | ---------------- |
|---|
7
| 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.