(62 days)
Not Found
No
The document describes a mechanical implant component (Locking Plug) and its intended use in hip replacement surgery. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is used in total hip replacement procedures to alleviate pain and disability caused by various hip joint conditions. This direct intervention to improve a patient’s health condition classifies it as a therapeutic device.
No
The device description indicates that the S-ROM Hip System - Locking Plug is a component used in total hip replacement procedures to resist disengagement from the shell/liner assembly, rather than for diagnosing conditions.
No
The device description clearly describes a physical component (Locking Plug) with a head, body, internal threading, external serrations, and a lip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the S-ROM Hip System - Locking Plug is a physical component (a plug) used in total hip replacement surgery. It is an implantable device.
- Intended Use: The intended use describes its application in surgical procedures to address structural damage in the hip joint. This is a surgical intervention, not a diagnostic test performed on a sample.
Therefore, the S-ROM Hip System - Locking Plug is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The S-ROM Hip System - Locking Plug has the same indications for use as the S-ROM Hip System - Locking Pin. They are both indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from:
-
- rheumatoid arthritis.
-
- osteoarthritis,
-
- post-traumatic arthritis,
-
- collagen disorders,
-
- avascular necrosis, and
- ર્ભ nonunion of femoral fractures.
Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with:
-
- congenital hip dysplasia,
-
- protrusio acetabuli.
-
- slipped capital femoral epiphysis,
-
- and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Product codes
87JDI
Device Description
The Locking Plug consists of a head and body. The head has both internal threading and external serrations (barbs). The internal threading allows attachment of the insertion tool to the Locking Plug. The body is cylindrical with an external lip. Both the external serrations of the head and the lip of the Locking Plug body aid in resisting disengagement of the Locking Plug from the shell/liner assembly. The Locking Plug is available in both 3.5 mm and 5.0 mm sizes.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
OCT 17 1996
Summary of Safety and Effectiveness Data for the S-ROM Hip System - Locking Plug
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
Jennifer L. Morse Associate Regulatory Affairs Specialist Phone: (508) 880-8417 (508) 828-3212 Fax:
Name of Device
Proprietary Name: S-ROM Hip System - Locking Plug Locking Plug Common Name: Hip joint metal/polymer semi-constrained cemented prosthesis Classification Name: Regulatory Class: Class II by 21 CFR § 888.3350 Product Code No .: 87JDI Owner/Operator No .: 9001269
Device Classification
This device has been placed in Class II for Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR § 888.3350.
Statement of Substantial Equivalence
The S-ROM Hip System - Locking Plug is substantially equivalent to the Locking Pin currently marketed in the United States under both #K870271 and K924492.
The subject device is composed of the same material as the Locking Pin (Ti-6Al-4V Titanium Alloy). Further, the intended use, design, and manufacture of the Locking Plug are substantially equivalent to the currently distributed Locking Pin. Additionally, the packaging and method of sterilization utilized for the Locking Plug are the same as those used for the Locking Pin.
1
The S-ROM Hip System - Locking Plug has the same indications for use as the S-ROM Hip System - Locking Pin. They are both indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from:
-
- rheumatoid arthritis.
-
- osteoarthritis,
-
- post-traumatic arthritis,
-
- collagen disorders,
-
- avascular necrosis, and
- ર્ભ nonunion of femoral fractures.
Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with:
-
- congenital hip dysplasia,
-
- protrusio acetabuli.
-
- slipped capital femoral epiphysis,
-
- and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Physical Description
The Locking Plug consists of a head and body. The head has both internal threading and external serrations (barbs). The internal threading allows attachment of the insertion tool to the Locking Plug. The body is cylindrical with an external lip. Both the external serrations of the head and the lip of the Locking Plug body aid in resisting disengagement of the Locking Plug from the shell/liner assembly. The Locking Plug is available in both 3.5 mm and 5.0 mm sizes.