(27 days)
No
The document describes a simple mechanical device (an acetabular dome hole plug) and a labeling change. There is no mention of AI, ML, image processing, or any data-driven analysis or decision-making process associated with the device's function.
Yes
The device is intended for use in hip arthroplasty to treat painful, disabling joint disease of the hip, revision of unsuccessful procedures, and other clinical management problems, which are therapeutic indications.
No
The device described is an "Acetabular Dome Hole Plug" used in hip arthroplasty to seal acetabular shells. Its function is to be part of a surgical implant, not to diagnose a condition or disease.
No
The device description clearly describes a physical, threaded plug used to seal acetabular shells, which is a hardware component. The submission is for labeling modifications to this physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications clearly describe the device's use in surgical procedures for hip arthroplasty, addressing conditions like arthritis, avascular necrosis, and revision surgeries. This is a surgical implant, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical implant (Acetabular Dome Hole Plug) used to seal acetabular shells in hip replacements. It does not mention any reagents, assays, or procedures for analyzing biological specimens.
- Performance Studies: The performance studies mentioned are non-clinical and clinical testing related to the device's function as an implant, not studies evaluating the accuracy of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
Indications: In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous. Indications for use when used with the Trident II Acetabular Shells.
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liners
The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident II Acetabular Shells are indicated for cementless use only.
Product codes
LPH, KWZ, LZO, MEH, JDI
Device Description
The Acetabular Dome Hole Plug, originally cleared via K942809, is an optional device used to seal acetabular shells. The Acetabular Dome Hole Plug has a threaded disc profile that can be screwed into the threaded dome hole of an acetabular shell sealing the device. Once assembled, the inferior face of the Acetabular Dome Hole Plug will be flush with the internal surface of the acetabular shell.
This Special 510(k) submission proposes labeling modifications to the package insert that was previously cleared in K191358 for the Acetabular Dome Hole Plug for use with the compatible Stryker Acetabular Shells. Specifically, the proposed labeling change is to remove the contraindication related to obesity and replace it with a warning statement concerning patient weight.
There is no change to the design (e.g., materials, dimensions, etc.) of the Acetabular Dome Hole Plug and no change to the direction for use of the device. The intended use, packaging, and sterilization of the Acetabular Dome Hole Plug device also remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
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
Non-Clinical Testing: Performance testing was not required in support of the labeling modifications to remove the obesity contraindication from, and add warning language concerning patient weight to, the package insert. The compatible acetabular shells do not contraindicate obesity. Since Acetabular Dome Hole Plug is an accessory to the shell, it is not practical to have a contraindication for an accessory device that is in conflict with the parent device. Based on the definitions for "contraindications" and "warnings" from the FDA's Device Labeling Guidance #G91-1 (Blue Book Memo), obesity should not be considered a contraindication to total hip arthroplasty, but rather a warning that should be adequately assessed by the surgeon and clearly communicated to the patient. The revisions to the Acetabular Dome Hole Plug package insert do not present any new issues of safety or effectiveness.
Clinical Testing: Clinical testing was not required as a basis to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 9, 2022
Howmedica Osteonics Corp., dba Stryker Orthopaedics Lin Song Senior Manager, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K220376
Trade/Device Name: Acetabular Dome Hole Plug Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, KWZ, LZO, MEH, JDI Dated: February 8, 2022 Received: February 10, 2022
Dear Lin Song:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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-regulatoryassistance/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 Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220376
Device Name Acetabular Dome Hole Plug
Indications for Use (Describe)
Indications:
In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous. Indications for use when used with the Trident II Acetabular Shells.
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liners
• The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident II Acetabular Shells are indicated for cementless use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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."
4
510(k) Summary
| Sponsor: | Howmedica Osteonics Corp dba Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lin Song
Senior Manager, Regulatory Affairs
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
lin.song@stryker.com
Phone: (201) 831-6617 |
| Date Prepared: | February 8, 2022 |
| Proprietary Name: | Acetabular Dome Hole Plug |
| Common Name: | Acetabular Implant Device |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR §888.3358)
Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR §888.3350)
Hip joint metal/ceramic/polymer, semi-constrained cemented or non-Porous uncemented (21 CFR §888.3353)
Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR §888.3310) |
| Product Codes: | LPH, KWZ, LZO, MEH, JDI |
Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed:
5
Legally Marketed Reference Devices Supporting Substantial Equivalence:
- Stryker Orthopaedics Total Hip Systems Labeling Update (K153345) .
Device Description
The Acetabular Dome Hole Plug, originally cleared via K942809, is an optional device used to seal acetabular shells. The Acetabular Dome Hole Plug has a threaded disc profile that can be screwed into the threaded dome hole of an acetabular shell sealing the device. Once assembled, the inferior face of the Acetabular Dome Hole Plug will be flush with the internal surface of the acetabular shell.
This Special 510(k) submission proposes labeling modifications to the package insert that was previously cleared in K191358 for the Acetabular Dome Hole Plug for use with the compatible Stryker Acetabular Shells. Specifically, the proposed labeling change is to remove the contraindication related to obesity and replace it with a warning statement concerning patient weight.
There is no change to the design (e.g., materials, dimensions, etc.) of the Acetabular Dome Hole Plug and no change to the direction for use of the device. The intended use, packaging, and sterilization of the Acetabular Dome Hole Plug device also remain unchanged.
Indications for Use
Indications
- . In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.
Indications for use when used with the Trident II Acetabular Shells.
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
6
· Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liners
• The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident II Acetabular Shells are indicated for cementless use only.
Summary of Technological Characteristics
There are no changes to the technological characteristics of the subject Acetabular Dome Hole Plug due to the revision to the labeling. The Acetabular Dome Hole Plug has identical design and is manufactured from the same materials as the predicate device. The way the Acetabular Dome Hole Plug interacts with the compatible Stryker Acetabular Shells remains unchanged.
Non-Clinical Testing
Performance testing was not required in support of the labeling modifications to remove the obesity contraindication from, and add warning language concerning patient weight to, the package insert. The compatible acetabular shells do not contraindicate obesity. Since Acetabular Dome Hole Plug is an accessory to the shell, it is not practical to have a contraindication for an accessory device that is in conflict with the parent device.
Based on the definitions for "contraindications" and "warnings" from the FDA's Device Labeling Guidance #G91-1 (Blue Book Memo), obesity should not be considered a
7
contraindication to total hip arthroplasty, but rather a warning that should be adequately assessed by the surgeon and clearly communicated to the patient.
The revisions to the Acetabular Dome Hole Plug package insert do not present any new issues of safety or effectiveness.
Clinical Testing
Clinical testing was not required as a basis to demonstrate substantial equivalence.
Conclusion
The subject Acetabular Dome Hole Plug is substantially equivalent to the predicate Acetabular Dome Hole Plug cleared in K942809 and K191358. Device comparison demonstrated that the subject Acetabular Dome Hole Plug is identical in design, materials, operational principles, and performance characteristics to its predicate. The proposed labeling modifications do not affect the safety or effectiveness of the subject device.