510(k) · Cleared
Recalled · Class II · 2016Abg Iii Monolithic Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Cleared on Aug 16, 2013 as substantially equivalent to K110807 (Stryker Corp., 2011) and 2 other predicates after a 268-day review. Its family tree reaches back 6 generations to 1994. 30 later devices descend from it. It has been recalled once.
- Decided
- Aug 16, 2013
- Review
- 268 days
- Class
- Class II
- Product code
- MAY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921308 (1994). 22 ancestors in all, the oldest K921301 (1994). 30 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 5 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 4 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 3 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 2 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- 1 generation backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- This deviceK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013
- Descendant · cites it directly · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 2 generations on · 10 of its ownK171768 Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · cites it directly21descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · 2 generations on10descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −5 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −4 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −3 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −2 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| −1 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| 0 (this device) | K123604 | Abg Iii Monolithic Hip Stem | Howmedica Osteonics Corp. | 2013 | — |
| +1 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +2 | K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017 | 12 |
| +2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +2 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K110807 | Abg II Monolithic Hip Stem | 2011 |
| * | K103479 | Novel Tapered Hip StemSummary page 1…Codes EPH, MBL) Legally Marketed Device to Which Substantial Equivalence is Claimed: ABC® 11 Monolithic Hip Stem KI 10807 Accolade® 11 Hip Stem K103479, K120578 Device Description: Howmedica Osteonics is introducing a monolithic, tion-porous coated femoral hip prosthesis, which i… | 2011 |
| * | K120578 | Accolade II Hip StemSummary page 1…H, MBL) Legally Marketed Device to Which Substantial Equivalence is Claimed: ABC® 11 Monolithic Hip Stem KI 10807 Accolade® 11 Hip Stem K103479, K120578 Device Description: Howmedica Osteonics is introducing a monolithic, tion-porous coated femoral hip prosthesis, which is intende… | 2012 |
What descends from it? (30)
See all 303 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2016 | Class II | Z-0875-2016 | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 13 of the 22 ancestors have a recall of any class.
- Of its descendants, K143085 (Stryker Orthopaedics, 2015) has gone furthest, with 21 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. 2013, 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: 1. noninfiammatory 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 fractures, and trochanteric fractures of the proximal femur with bead involvement that are unmanageable using other techniques.…
Read the full statement (139 words)
The indications for use for total hip arthroplasty include:
1. noninfiammatory 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 fractures, and trochanteric fractures of the proximal femur with bead involvement that are unmanageable using other techniques.
Additional indication specific to use of AnatoTm 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, bane loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
The AnatoTm 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/K123604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123604: Abg Iii 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/K123604
Report an extraction error
Are you the manufacturer?
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