# K020615: Super Secur-Fit HA Hip Stems and Super Secur-Fit Plus HA Hip Stems

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 13, 2002 after 77 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Secur-Fit™ HA Hip Stems (6051A series), 132° neck angle: named in the summary without a submission number
- (no number) Secur-Fit™ HA Hip Stems (6052A series), 127° neck angle: named in the summary without a submission number
- (no number) Secur-Fit™ Plus HA Hip Stems (6054 A series), 127° neck angle: named in the summary without a submission number

## Most influential descendants
- K041170: Secur-Fit HA and Secur-Fit Plus Hip Stems (2004), 18 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own

## Recalls of this device
- Jan 14, 2009 · Not classified · Z-0556-2010: Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
- Jan 14, 2009 · Not classified · Z-0557-2010: Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
- Jan 6, 2009 · Not classified · Z-1387-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1385-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1384-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1680-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1386-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1383-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

## Indications for use
The subject hip stems are single-use devices intended for use in total hip replacerfierit. They are designed for cementless fixation. They are intended for mechanical assembly to mating Howmedica V40™ Femoral Heads (excluding size +16mm (XX Long) V40 Femoral Heads). 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 femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K020615
Methodology: https://510kreport.com/methodology