# K122853: Novel Fit and Fill Stem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 1, 2013 after 136 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921308 (1994). 20 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 2.
- K120578: Accolade II Hip Stem, Howmedica Osteonics (2012) Summary page 2.
- (no number) Secur-Fit HA Hip: named in the summary without a submission number
- (no number) Rejuvenate Monolithic Hip Stem: named in the summary without a submission number

## Most influential descendants
- K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach (2015), 21 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K171768: Trident® II Acetabular System (2017), 10 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

## Indications for use
Indications for use include: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners: 1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Source page: https://510kreport.com/device/K122853
Methodology: https://510kreport.com/methodology