# K223103: BethaLoc® stem cementless HA

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Jun 20, 2023 after 263 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931641 (1994). 325 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203420: EcoFit® Hip System, Implantcast GmbH (2021) Summary page 7.
- K163577: Ecofit® Hip System, Implantcast GmbH (2017) Summary page 7.
- K180263: EcoFit Vit E Acetabular System, Implantcast GmbH (2018) Summary page 7.
- K191569: Implantcast ic-Bipolar Head System, Implantcast GmbH (2019) Summary page 7.
- K122296: SL-Plus Mia Femoral Stems with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 7.
- K143096: SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA, Smith & Nephew, Inc. (2015) Summary page 7.
- K130099: Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019, Encore Medical L.P. (2013) Summary page 7.

## Most influential descendants
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
The EcoFit®, implaFit® and BethaLoc® hip stems are indicated for use in cases of: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and • Revision of previously failed total hip arthroplasty. The EcoFit®, implaFit® and BethaLoc® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis • Rheumatoid arthritis • Correction of functional deformity • Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. The EcoFit® hip stems, the implaFit® hip stems cementless and the BethaLoc® hip stems are intended for uncemented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation. The ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the BethaLoc® hip stems and EcoFit® Hip System for the following indications: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis • Rheumatoid arthritis • Correction of functional deformity • Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K223103
Methodology: https://510kreport.com/methodology