(270 days)
P960047
No
The document describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an uncemented prosthesis intended to replace a hip joint, which is a therapeutic intervention.
No
Explanation: The device is an uncemented prosthesis intended to replace a hip joint. It is a medical implant used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical implantable prosthesis made of materials like UHMWPE, Titanium Alloy, and Cobalt Chrome, and describes mechanical testing. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "uncemented prosthesis intended to replace a hip joint." This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of the hip prosthesis (liner, bearing, rings) and the materials used. This aligns with a medical device intended for implantation, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies described focus on mechanical testing (attachment loads, dislocation resistance, range of motion) and pyrogen testing, which are relevant for implantable devices, not IVDs.
Therefore, the R3™ Constrained Liner Acetabular System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.
Product codes
KWZ
Device Description
Subject of this Traditional premarket notification is the addition of new liner sizes to the Smith & Nephew R3" Constrained Liner Acetabular System. The R3 Constrained Liner Acetabular System currently consists of the R3 Constrained Liner offered in sizes of 52mm to 66/70mm cleared via premarket notification K111635. The proposed devices are additional sizes to the R3 Constrained Liners that were previously cleared. The proposed devices will be offered in sizes of 48mm, 50mm, 72-74mm, and 76-80mm, and will be marketed as part of the R3 Constrained Liner Acetabular System.
The new R3 Constrained Liner sizes are line additions to the primary predicate R3 Constrained Liners cleared via premarket notification K111635. The subject devices are similar to the primary predicate R3 Constrained Liners in that they are a multipiece acetabular component consisting of a bipolar bearing that articulates with a captured outer polyethylene liner, locking ring, and outer poly support ring. The subject devices and the primary predicate R3 Constrained Liners utilize a tripolar design allowing motion at two interfaces: the femoral head with the bipolar bearing and the bipolar bearing with the outer liner. The subject devices are identical in design to the cleared R3 Constrained Liners, with the exception that they are smaller or larger in overall size. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference predicate Osteonics Constrained Acetabular Inserts (P960047). The subject devices utilize seven components manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), forged Titanium Alloy (Ti-6Al-4V), and Cobalt Chrome (CoCr).
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
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)
Mechanical testing has been conducted for the subject devices to address the attachment loads (push-in, pull-out, shuck-out, and push-out) and dislocation resistance. The range of motion (ROM) has also been evaluated. A review of the testing has demonstrated that there are no new issues related to safety or effectiveness of the subject devices. Clinical data was not needed to support substantial equivalence.
The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of less than or equal to 20 EU/device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111635, K122139, K021803, K033442, K113848, K033273
Reference Device(s)
P960047
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
June 19, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Dongeun Kim Regulatory Affairs Specialist I 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K162641 Trade/Device Name: Smith & Nephew, Inc. R3TM Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWZ Dated: May 18, 2017 Received: May 19, 2017
Dear Dongeun Kim:
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 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
1
the quality systems (OS) 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,
Mark N. Melkerson -S
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) K162641
Device Name Smith & Nephew, Inc. R3TM Constrained Liner
Indications for Use (Describe)
The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.
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.
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/2 description: The image shows the logo for Smith & Nephew. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The text "We are" is in gray, while "smith&nephew" is in orange, matching the color of the flower symbol. The logo is simple and clean, with a focus on the company name.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|----------------------------------------------------------------------------------------------|
| Date of Summary: | June 19, 2017 |
| Contact Person and Address: | Dongeun Kim
Regulatory Affairs Specialist I
T 901-399-1151
F 901-566-7120 |
| Name of Device: | Smith & Nephew, Inc. R3TM Constrained Liner |
| Common Name: | Acetabular Liner, Constrained |
| Device Classification Name and
Reference: | 21 CFR 888.3310 Hip Joint Metal/Polymer Constrained
Cemented or Uncemented Prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KWZ |
Device Description
Subject of this Traditional premarket notification is the addition of new liner sizes to the Smith & Nephew R3" Constrained Liner Acetabular System. The R3 Constrained Liner Acetabular System currently consists of the R3 Constrained Liner offered in sizes of 52mm to 66/70mm cleared via premarket notification K111635. The proposed devices are additional sizes to the R3 Constrained Liners that were previously cleared. The proposed devices will be offered in sizes of 48mm, 50mm, 72-74mm, and 76-80mm, and will be marketed as part of the R3 Constrained Liner Acetabular System.
The new R3 Constrained Liner sizes are line additions to the primary predicate R3 Constrained Liners cleared via premarket notification K111635. The subject devices are similar to the primary predicate R3 Constrained Liners in that they are a multipiece acetabular component consisting of a bipolar bearing that articulates with a captured outer polyethylene liner, locking ring, and outer poly support ring. The subject devices and the primary predicate R3 Constrained Liners utilize a tripolar design allowing motion at two interfaces: the femoral head with the bipolar bearing and the bipolar bearing with the outer liner. The subject devices are identical in design to the cleared R3 Constrained Liners, with the exception that they are smaller or larger in overall size. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference predicate Osteonics Constrained Acetabular Inserts (P960047). The subject devices utilize seven components manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), forged Titanium Alloy (Ti-6Al-4V), and Cobalt Chrome (CoCr).
4
Intended Use
The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation. bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.
Technological Characteristics
Mechanical testing has been conducted for the subject devices to address the attachment loads (push-in, pull-out, shuck-out, and push-out) and dislocation resistance. The range of motion (ROM) has also been evaluated. A review of the testing has demonstrated that there are no new issues related to safety or effectiveness of the subject devices. Clinical data was not needed to support substantial equivalence.
The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of less than or equal to 20 EU/device.
Substantial Equivalence Information
The intended use, indications for use, and technological characteristics of the subject R3 Constrained Liners are substantially equivalent to the predicate devices. A comparison of the subject devices to the predicate devices are provided in Table 5.1 below.
5
| Design Features | Subject R3
Constrained
Liner | 510(k) Number | Manufacturer | | Indications for Use/Intended Use | R3 Constrained
Liner (Primary
Predicate) | R3 Constrained
Liner (Additional
Predicate) | REFLECTION
Constrained
Liner (Additional
Predicate) | R3 XLPE Liner
(Additional
Predicate) | DePuy Self-Centering
Hip Prosthesis
(Additional Predicate) | Osteonics
Constrained
Acetabular
Insert
(Reference
Predicate) | | | | | | | | | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------|
| | The R3
Constrained Liner
Acetabular
System is an
uncemented
prosthesis
intended to
replace a hip joint.
The Constrained
Liner is intended
for primary or
revision patients
at high risk for hip
dislocation due to
a history of prior
dislocation, bone
loss, soft tissue
laxity,
neuromuscular
disease, or intra-
operative
instability and for
whom all other
options to
constrained
acetabular
components have | K111635 | Smith & Nephew,
Inc. | The R3
Constrained Liner
Acetabular
System is a
cemented or
uncemented
prosthesis
intended to
replace a hip joint.
The Constrained
Liner is intended
for primary or
revision patients
at high risk for hip
dislocation due to
a history of prior
dislocation, bone
loss, soft tissue
laxity,
neuromuscular
disease, or intra-
operative
instability and for
whom all other
options to
constrained
acetabular | | The R3
Constrained Liner
Acetabular
System is a
cemented or
uncemented
prosthesis
intended to
replace a hip joint.
The Constrained
Liner is intended
for primary or
revision patients
at high risk for hip
dislocation due to
a history of prior
dislocation, bone
loss, soft tissue
laxity,
neuromuscular
disease, or intra-
operative
instability and for
whom all other
options to
constrained
acetabular | K122139 | Smith & Nephew,
Inc. | The
REFLECTION
Constrained Liner
Acetabular
System is a
cemented or
uncemented
prosthesis
intended to
replace a hip joint.
The Constrained
Liner is intended
for primary or
revision patients
at high risk for hip
dislocation due to
a history of prior
dislocation, bone
loss, soft tissue
laxity,
neuromuscular
disease, or intra'
operative
instability and for
whom all other
options to
constrained | K021803,
K033442 | Smith & Nephew,
Inc. | Hip components
are indicated for
individuals
undergoing
primary and
revision surgery
where other
treatments or
devices have
failed in
rehabilitating hips
damaged as a
result of trauma or
noninflammatory
degenerative joint
disease (NIDJD)
or any of its
composite
diagnoses of
osteoarthritis,
avascular
necrosis, traumatic
arthritis, slipped
capital epiphysis,
fused hip, fracture
of the pelvis, and
diastrophic variant | K113848 | Smith & Nephew,
Inc. | Indications for the
UltimaTM Unipolar
heads and the Self-
CenteringTM Hip
Prostheses previously
cleared for Hemi-Hip
Arthroplasty remain
unchanged. Additions to
the indications for use
include:
Self-CenteringTM Hip
Prostheses and unipolar
femoral heads are also
intended to be used for
total hip arthroplasty to
provide increased patient
mobility and reduce pain
by replacing the
damaged hip joint
articulation in patients
where there is evidence
of sufficient sound bone
to seat and support the
components, when used
in conjunction with a
UHMWPE bearing
surface having an inside | K033273 | DePuy Orthopaedics,
Inc. | The Osteonics
Constrained
Acetabular Insert
is indicated as a
component of a
total hip
prosthesis in
primary or
revision patients
at high risk of hip
dislocation, bone
loss, joint or soft
tissue laxity,
neuromuscular
disease or
intraoperative
instability. | P960047 | Howmedica
Osteonics Corp. |
ਣ のない 이후 പ് d Liner to the Constrainc rs ണ്ട ട് ത ਾਪੂ: rison of t .. ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ hle
5-3
6
| K162641 | |||
|---|---|---|---|
| Size Offering | |||
| (Outer Diameter) | Materials | Sterilization | |
| Constrained Liner | |||
| is intended for | |||
| single use only. | |||
| The R3 | |||
| components have | |||
| been considered. | 48mm, 50mm, 72- | ||
| 74mm, and 76- | |||
| 80mm | UHMWPE, Ti-6Al- | ||
| 4V, CoCr | Ethylene Oxide | ||
| Constrained Liner | |||
| is intended for | |||
| single use only. | |||
| The R3 | |||
| components have | |||
| been considered. | 52mm to | ||
| 66/70mm | UHMWPE, Ti-6Al- | ||
| 4V, CoCr | Ethylene Oxide | ||
| Constrained Liner | |||
| is intended for | |||
| single use only. | |||
| The R3 | |||
| components have | |||
| been considered. | 52mm to | ||
| 66/70mm | UHMWPE, Ti-6Al- | ||
| 4V, CoCr | Ethylene Oxide | ||
| acetabular | |||
| components have | |||
| been considered. | 46/48mm- | ||
| 70/76mm | UHMWPE, Ti-6Al- | ||
| 4V, CoCr | Ethylene Oxide | ||
| Hip components | |||
| are also indicated | |||
| for inflammatory | |||
| degenerative joint | |||
| disease including | |||
| rheumatoid | |||
| arthritis, arthritis | |||
| secondary to a | |||
| variety of diseases | |||
| and anomalies, | |||
| and congenital | |||
| dysplasia; | |||
| treatments of | |||
| nonunion, femoral | |||
| neck fracture, and | |||
| trochanteric | |||
| fractures of the | |||
| proximal femur | |||
| with head | |||
| involvement that | |||
| are unmanageable | |||
| using other | |||
| techniques; | |||
| endoprosthesis, | |||
| femoral | |||
| osteotomy, or | |||
| Girdlestone | |||
| resection; fracture- | |||
| dislocation of the | |||
| hip; and correction | |||
| of deformity. | 22mm-36mm | XLPE | Ethylene Oxide |
| diameter corresponding | |||
| to outside diameter of | |||
| the metallic cup that is | |||
| utilized. Use in total hip | |||
| replacement is indicated | |||
| in the following additional | |||
| conditions: |
- A severely painful
and/or disabled joint from
osteoarthritis, traumatic
arthritis, rheumatoid
arthritis, or congenital hip
dysplasia - Failed previous hip
surgery including joint
reconstruction, internal
fixation, arthrodesis,
hemiarthroplasty, or total
hip replacement. | 39mm-57mm | UHMWPE | |
| | 50mm-74mm | UHMWPE, Ti-
6Al-4V, CoCr | |
Page 4 of 5
5-4
7
Conclusion
This Traditional 510(k) Premarket Notification is being submitted to request clearance for the new R3 Constrained Liner sizes of 48mm, 50mm, 72mm-74mm, and 76mm-80mm. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject devices are substantially equivalent to the above predicate devices.