(254 days)
Not Found
No
The summary describes a mechanical hip implant system and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a hip system, which is a prosthetic used to replace a diseased or damaged hip joint, addressing conditions like coxarthrosis and necrosis of the femoral head. This directly treats a medical condition and restores function, classifying it as a therapeutic device.
No
This device is a hip implant system intended for replacement of the hip joint in patients with various hip diseases or injuries. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy, Cobalt Chromium Molybdenum, and ceramic, which are implanted in the body. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a hip joint due to various conditions affecting mobility. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a physical implant (hip prosthesis) made of materials like titanium alloy and cobalt chromium. It is designed to be surgically implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
Therefore, the LINK® SP-CL® and LCU® Hip System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LINK® SP-CL® and LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated is indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The hip system is indicated for the following conditions:
- Primary and secondary coxarthrosis
- Osteoarthritis
- Necrosis of the femoral head
- Femoral neck fractures
The stems are indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The LINK® SP-CL® and LCU® Systems include a straight stem (LCU® Hip Prosthesis) and an anatomically curved stem (SP-CL® Hip Prosthesis). Both stems are comprised of titanium alloy (Ti6A14V, ISO 5832-3, ASTM F136) available with corundum blasted PoroLink® (microporous) surface or HX® (calcium phosphate) (ASTM F1609) coated. The stems are available in a range of sizes, lengths, and offsets. The stems connect to femoral heads that are manufactured from Cobalt Chromium Molybdenum casting alloy (CoCrMo) or ceramic (BIOLOX® forte and BIOLOX® delta) via 12/14 Morse taper. In total joint use, the femoral head articulates against Signature Orthopedics' Origin crosslinked acetabular liners (#K121297) fixed in a cementless shell. Femoral heads part of this submission (BIOLOX® forte / delta head and LINK® Prosthesis Head B) are not intended for hemiarthroplasty use. Both the LCU® and SP-CL® stems are intended for cementless use to replace the hip joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 performance testing was conducted with consideration to "Guidance for Industry and FDA Staff, Non-Clinical Information for Femoral Stem Prosthesis, September 17, 2007".
Non-clinical performance testing included: femoral stem fatigue tests per ISO 7206-4 and ISO 7206-8; femoral neck segment fatigue tests per ISO 7206-6; ASTM F2068; Modular Connections, Fretting Corrosion Testing per ASTM F1875-98; Range of Motion analysis of the LINK® SP-CL® and LCU® Hip Systems and Component Testing of ceramic heads.
The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate device.
There was no clinical performance testing required for this device.
Sterilization and cleaning studies validate the procedures used, per the applicable standards of AAMI ST 77:2006, AAMI ST79, ISO 17665-1, ISO 11138-3, AAMI TIR 12:2010, and AAMI TIR 30.
Routine Endotoxin Testing is performed according to AAMI ST 72.
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.
K123991, K070554, K042992, K854465
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
Waldemar Link GmbH & Co. KG Mr. André Von Malotki Regulatory Affairs Manager Oststraße 4-10 Norderstedt, Germany 22844
Re: K161840
Trade/Device Name: LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated 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, MEH Dated: February 16, 2017 Received: February 16, 2017
Dear Mr. André Von Malotki:
This letter corrects our substantially equivalent letter of March 16, 2017.
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
1
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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161840
Device Name
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
Indications for Use (Describe)
The LINK® SP-CL® and LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated is indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The hip system is indicated for the following conditions:
- Primary and secondary coxarthrosis
- Osteoarthritis
- Necrosis of the femoral head
- Femoral neck fractures
The stems are indicated for cementless use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & CO. KG |
|---|---|
| Barkhausenweg 10 | |
| 22339 Hamburg, Germany | |
| Phone: +49-40-539950 | |
| Facility Registration #:3004371426 (Oststraße 4-10) | |
| Contact Person: | Waldemar Link GmbH & Co. KG |
| André von Malotki (Regulatory Affairs) | |
| Oststraße 4-10 | |
| Norderstedt, GERMANY 22844 | |
| Phone: +49-40 53995-448 | |
| Fax: +49-40 53995-174 | |
| E-Mail: a.vonmalotki@linkhh.de | |
| Date Prepared: | March 10th, 2017 |
| Trade Name: | LINK® SP-CL® Hip System PoroLink® (microporous) and |
| HX® (CaP) coated | |
| & | |
| LINK® LCU® Hip System PoroLink® (microporous) and | |
| HX® (CaP) coated | |
| Common Name: | Hip Prosthesis |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented |
| or nonporous uncemented prosthesis; 21 CFR §888.3353, | |
| product code LZO, MEH | |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | Corail AMTTM Hip Prosthesis by DePuy Orthopaedics, |
| #K123991 cleared September 16, 2013; #K070554 cleared | |
| September 11, 2007; #K042992 cleared February 11, 2005 | |
| LINK® Contour Ribbed Hip Prosthesis, | |
| #K854465 cleared February 2, 1986 |
4
Device Description:
The LINK® SP-CL® and LCU® Systems include a straight stem (LCU® Hip Prosthesis) and an anatomically curved stem (SP-CL® Hip Prosthesis). Both stems are comprised of titanium alloy (Ti6A14V, ISO 5832-3, ASTM F136) available with corundum blasted PoroLink® (microporous) surface or HX® (calcium phosphate) (ASTM F1609) coated. The stems are available in a range of sizes, lengths, and offsets. The stems connect to femoral heads that are manufactured from Cobalt Chromium Molybdenum casting alloy (CoCrMo) or ceramic (BIOLOX® forte and BIOLOX® delta) via 12/14 Morse taper. In total joint use, the femoral head articulates against Signature Orthopedics' Origin crosslinked acetabular liners (#K121297) fixed in a cementless shell. Femoral heads part of this submission (BIOLOX® forte / delta head and LINK® Prosthesis Head B) are not intended for hemiarthroplasty use. Both the LCU® and SP-CL® stems are intended for cementless use to replace the hip joint.
Indications for Use:
The LINK® SP-CL® and LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated is indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The hip system is indicated for the following conditions:
- -Primary and secondary coxarthrosis
- -Osteoarthritis
- Necrosis of the femoral head -
- -Femoral neck fractures
The stems are indicated for cementless use only.
Comparison to Predicate Device:
Consistent with FDA's guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (July 28, 2014) (510(k) Guidance Document), the LINK® SP-CL® and LCU® Hip Systems are substantially equivalent to DePuy Orthopaedics' Corail AMT Hip Prosthesis (#K123991, #K070554, #K042992) and the LINK® Contour Ribbed Hip Prosthesis (#K854465). The LINK® SP-CL® and LCU® Hip Systems have the same intended use and the same or similar indications, technological characteristics, and principles of operation as the predicate devices.
5
Performance Data:
Non-Clinical Performance and Conclusions:
Non-Clinical performance testing was conducted with consideration to "Guidance for Industry and FDA Staff, Non-Clinical Information for Femoral Stem Prosthesis, September 17, 2007".
Non-clinical performance testing included: femoral stem fatigue tests per ISO 7206-4 and ISO 7206-8; femoral neck segment fatigue tests per ISO 7206-6; ASTM F2068; Modular Connections, Fretting Corrosion Testing per ASTM F1875-98; Range of Motion analysis of the LINK® SP-CL® and LCU® Hip Systems and Component Testing of ceramic heads.
The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate device.
Clinical Performance:
There was no clinical performance testing required for this device.
Cleaning, Sterilization and Routine Endotoxin Testing:
Sterilization and cleaning studies validate the procedures used, per the applicable standards of AAMI ST 77:2006, AAMI ST79, ISO 17665-1, ISO 11138-3, AAMI TIR 12:2010, and AAMI TIR 30.
Routine Endotoxin Testing is performed according to AAMI ST 72.
Conclusion:
The LINK® LCU® and SP-CL® Systems have the same intended use and the same or similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the LINK® LCU® and SP-CL® Systems and its predicate device do not raise any new issues of safety or effectiveness.
The subject devices LINK® SP-CL® and LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated are substantially equivalent to the predicate device identified in this premarket notification.