# K041170: Secur-Fit HA and Secur-Fit Plus Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 9, 2004 after 189 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941366 (1995). 5 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941366: Osteonics Omnifit AD-HA Hip Stem Series, Osteonics Corp. (1995) Summary page 2.
- K951517: Osteonics Secur-Fit HA Plus Hip Stem Series, Osteonics Corp. (1996) Summary page 2.
- K982032: Osteonics Omnifit HA Hip Stem Series, Osteonics Secur-Fit HA Hip Stem Series, Osteonics Primary Secur-Fit Plus Hip Stems, Osteonics Corp. (1998) Summary page 2.
- K990203: Osteonics Primary Secur-Fit Plus Hip Stems, Osteonics Corp. (1999) Summary page 2.
- K020615: Super Secur-Fit HA Hip Stems and Super Secur-Fit Plus HA Hip Stems, Howmedica Osteonics Corp. (2002) Summary page 2.

## Most influential descendants
- 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
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own

## Recalls of this device
- Nov 13, 2008 · Not classified · Z-0893-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
- Nov 13, 2008 · Not classified · Z-0894-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## Indications for use
The Osteonics® Secur-FitTM HA and Secur-FitTM Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The indications for use of the Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems as a Total Hip Replacement 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 non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K041170
Methodology: https://510kreport.com/methodology