510(k) · Cleared
ClearedAbg II Monolithic Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Cleared on May 25, 2011 as substantially equivalent to K092406 (Howmedica Osteonics Corp., 2009) after a 63-day review. Its family tree reaches back 1 generation to 2009. 31 later devices descend from it.
- Decided
- May 25, 2011
- Review
- 63 days
- Class
- Class II
- Product code
- MAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092406 (2009). 31 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK092406 Abg II Modular Hip StemHowmedica Osteonics Corp. · 2009 · Recalled
- This deviceK110807 Abg II Monolithic Hip StemStryker Corp. · 2011
- Descendant · cites it directly · 30 of its ownK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · Recalled
- Descendant · 2 generations on · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- Descendant · 2 generations on · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 3 generations on · 10 of its ownK171768 Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · Recalled
- Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · cites it directly30descendants
- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · 2 generations on21descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · 2 generations on17descendants
- K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · 3 generations on10descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092406 | Abg II Modular Hip Stem | Howmedica Osteonics Corp. | 2009 | 1 |
| 0 (this device) | K110807 | Abg II Monolithic Hip Stem | Stryker Corp. | 2011 | — |
| +1 | K123604 | Abg Iii Monolithic Hip Stem | Howmedica Osteonics Corp. | 2013 | 1 |
| +2 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| +2 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +3 | K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017 | 12 |
| +3 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092406 | Abg II Modular Hip StemSummary page 1…, 21 CFR §888.3358 (Product Codes LPH, MBL) Legally Marketed Device to Which Substantial Equivalence is Claimed: ABG TM 11 Modular Hip Stem K092406. Device Description: Howmtedica Osteonics is introducing a monolithic femoral hip prosthesis. The basic design of the ABGTM 11 M… | 2009 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123604 | Abg Iii Monolithic Hip Stem | 2013 | 30 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K123604 (Howmedica Osteonics Corp., 2013) has gone furthest, with 30 descendants of its own.
How does its category compare?
All MAY devicesMAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MAY
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MAY
Too few MAY 510(k)s in any year since 2007 to give a median.
Recalls per year · MAY
15in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAY
2in 2025
MAUDE reports naming product code MAY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 0 | — | 0 | 94 |
| 2015 | 0 | — | 0 | 115 |
| 2016 | 0 | — | 15 | 60 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for use for total hip arthroplasty 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, nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication…
Read the full statement (138 words)
The indications for use for total hip arthroplasty 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,
nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of ABGTM II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners:
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.
Stryker's ABGTM II Monolithic Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110807: Abg II Monolithic Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110807
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026