(59 days)
Not Found
No
The device description and indications for use describe mechanical components for hip replacement surgery. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is a therapeutic device because its intended use includes various hip procedures for conditions like degenerative joint disease, avascular necrosis, rheumatoid arthritis, correction of functional deformity, and treatment of fractures, all of which aim to treat or alleviate a medical condition.
No
This device is a collection of orthopedic implants (cables, femoral heads, mesh, plugs, centralizers, cups, stems) used for surgical repair and replacement in hip procedures, not for diagnosis.
No
The device description explicitly lists physical components such as cables, heads, mesh, plugs, centralizers, cups, and stems, which are all hardware.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The descriptions clearly state that these devices are intended for surgical procedures related to the hip, including reattachment of the trochanter, total and hemi hip arthroplasty, fracture fixation, and reinforcement of bone or tissue. These are all in vivo procedures, meaning they are performed within the living body.
- Device Description: The devices are described as components of Stryker Total Hip Systems, including cables, heads, mesh, plugs, centralizers, cups, and stems. These are all physical implants and surgical tools used directly on the patient's body.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. The devices described here are used inside the body for surgical reconstruction and repair.
N/A
Intended Use / Indications for Use
The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.
Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses include:
· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
· rheumatoid arthritis;
· correction of functional deformity;
· revision procedures where other treatments or devices have failed; and,
· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.
Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.
Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion. femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.
Product codes
JDI, JDQ, HRS, LRN, LYT, LPH, JDG, KWY, LZO
Device Description
The devices covered by this bundled submission are Stryker Total Hip Systems which include Dall-Miles cable system components, femoral heads, femoral mesh, Intramedullary Plug, Centralizer, acetabular cups, and femoral stems. All devices are commercially available and have been cleared in prior 510(k) submissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Femoral, Acetabulum
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical testing was not required as a basis for substantial equivalence.
Clinical testing was not required as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K213701, K233498, K202016, K121308, K193429
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2024
Howmedica Osteonics Corp. dba Stryker Orthopaedics Julia Bally Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K240418
Trade/Device Name: Stryker Orthopaedics Hip Systems Labeling Update Regulation Number: 21 CFR 888.3050 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, JDQ, HRS, LRN, LYT, LPH, JDG, KWY, LZO Dated: February 12, 2024 Received: February 13, 2024
Dear Julia Bally:
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.
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"
1
(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 OS 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.
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 mediation-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).
2
Sincerely,
Limin Sun -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
Submission Number (if known)
Device Name
Stryker Orthopaedics Hip Systems Labeling Update
Indications for Use (Describe)
DALL-MILES Cable System
The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- Rheumatoid arthritis;
-
- Correction of functional deformity;
-
Revision procedures where other treatments or devices have failed; and,
-
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
4
-
Rheumatoid arthritis;
-
Correction of functional deformity;
-
Revision procedures where other treatments or devices have failed; and,
-
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.
Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses include:
· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- · rheumatoid arthritis;
- · correction of functional deformity;
- · revision procedures where other treatments or devices have failed; and,
· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.
Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:
-
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 reconstructive techniques are less likely to achieve satisfactory results.
-
Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.
5
Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- rheumatoid arthritis;
-
- correction of functional deformity;
-
revision procedures where other treatments or devices have failed; and,
-
treatment of nonunion. femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
he-Counter Use (21 CFR 801 Subpart C)
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6
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Julia Bally
Regulatory Affairs Specalist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
201-831-6265
Julia.Bally@stryker.com |
| Alternate Contact | Shing Jen Tai
Principal Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
269-800-2088
shingjen.tai@stryker.com |
| Date Prepared: | 12- February-2024 |
| Proprietary Name: | Stryker Orthopaedics Hip Systems Labeling Update |
| Common Name: | Artificial Hip Replacement Components -Acetabular and Femora |
Classification Name:
888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis, 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, 888.3010 - Bone fixation cerclage, 888.3030 - Single/multiple component metallic bone fixation appliances and accessories, 888.3360 -Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis, 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product Codes: JDI, JDQ, HRS, LRN, LYT, LPH, JDG, KWY, LZO
Primary Predicate Device to Which Substantial Equivalence is Claimed:
- K213701: Exeter® X3® RimFit® Cup .
7
K240418 page 2 of 4
Additional Predicate Device Used to Support Substantial Equivalence:
- K233498: Stryker Orthopaedics Hip Systems Labeling Update
- K202016: Dall-Miles® Cable System ●
- K121308: HIP SYSTEMS ●
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup ●
Reason for 510(k) Submission:
The purpose of this "Change Being Effected" bundled submission is to add a contraindication to the labeling of the subject Stryker Orthopaedics Hip Systems Labeling Update devices.
Device Description:
The devices covered by this bundled submission are Stryker Total Hip Systems which include Dall-Miles cable system components, femoral heads, femoral mesh, Intramedullary Plug, Centralizer, acetabular cups, and femoral stems. All devices are commercially available and have been cleared in prior 510(k) submissions.
Intended Use:
In general, these devices are intended for use in primary or revision hip arthroplasty.
Indications:
DALL-MILES Cable System
The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:
-
Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
8
- Correction of functional deformity:
-
- Revision procedures where other treatments or devices have failed; and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- Rheumatoid arthritis:
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed; and,
-
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.
Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses include:
- · noninflammatory degenerative ioint disease including osteoarthritis and avascular necrosis:
- rheumatoid arthritis:
- correction of functional deformity:
- · revision procedures where other treatments or devices have failed; and,
- · treatment of nonunion. femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.
Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:
-
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 reconstructive techniques are less likely to achieve satisfactory results.
-
Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
9
The Exeter X3 RimFit Cup is intended for cemented use only.
Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:
-
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.
Summary of Technological Characteristics:
The technological characteristics of the subject devices are identical to those of the predicate devices.
Non-Clinical Testing:
Non-Clinical testing was not required as a basis for substantial equivalence.
Clinical Testing:
Clinical testing was not required as a basis for substantial equivalence.
Conclusion:
Based upon a comparison of the intended use, indications for use, design, materials, sterilization method, technical and performance characteristics, and operational principles, the subject devices are substantially equivalent to the predicate devices identified in this premarket notification.