# K143242: Rebel 3DKNEE System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: May 15, 2015 after 184 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 41 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020114: 3D KNEE, Encore Orthopedics, Inc. (2002) Summary page 4.
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712, Encore Medical L.P. (2010) Summary page 4.
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 4.
- K933539: Foundation Posterior Stabilized Knee, Encore Orthopedics, Inc. (1994) Summary page 4.
- K100900: Motivation Knee System, Encore Medical L.P. (2010) Summary page 4.
- K121727: Movation Knee System, Encore Medical L.P. (2012) Summary page 4.

## Most influential descendants
- K160342: EMPOWR PS Knee System (2016), 6 descendants of its own
- K180930: Empowr VVC Tibial Insert (2018), 3 descendants of its own
- K230169: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert (2023), 2 descendants of its own
- K173723: EMPOWR Universal Tibial Baseplate (2018), 2 descendants of its own
- K213793: EMPOWR Revision Knee (2022), 1 descendant of its own

## Recalls of this device
- Feb 16, 2026 · Class II · Z-2701-2026: Due to packaging discrepancy with incorrect product size mixed up.
- Feb 16, 2026 · Class II · Z-2700-2026: Due to packaging discrepancy with incorrect product size mixed up.
- Jan 15, 2026 · Class II · Z-1459-2026: Knee and Humeral socket implants contain incorrect labeling.
- Jan 5, 2026 · Class II · Z-1233-2026: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cau
- Jul 9, 2025 · Class II · Z-2286-2025: Knee implants contain incorrect labeling (size and/or side incorrect)
- Jul 9, 2025 · Class II · Z-2285-2025: Knee implants contain incorrect labeling (size and/or side incorrect)
- Jun 2, 2025 · Class II · Z-2126-2025: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surg
- Jun 2, 2025 · Class II · Z-2125-2025: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surg
- Dec 18, 2024 · Class II · Z-0766-2025: 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
- Dec 10, 2024 · Class II · Z-0761-2025: Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
- Aug 22, 2023 · Class II · Z-0102-2024: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery 
- Aug 12, 2022 · Class II · Z-0126-2023: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
- May 5, 2022 · Class II · Z-1257-2022: A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
- May 12, 2021 · Class II · Z-2104-2021: Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
- May 12, 2021 · Class II · Z-2103-2021: Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
- Feb 5, 2021 · Class II · Z-1524-2021: Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
- Nov 15, 2016 · Class II · Z-0711-2017: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: degenerative, post-traumatic or rheumatoid arthritis; avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; moderate valgus, varus or flexion deformities; treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications.

Source page: https://510kreport.com/device/K143242
Methodology: https://510kreport.com/methodology