510(k) · Cleared
ClearedOSS/Arcos IM Total Femur Rod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 14, 2015 as substantially equivalent to K033871 (Biomet, Inc., 2004) and 5 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Oct 14, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K921308 (1994). 48 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- 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 backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- This deviceK152621 OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015
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 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −1 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| 0 (this device) | K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 7 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K033871 | IM Total FemurSummary page 4…-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560) Legally marketed devices to which substantial equivalence is claimed: K033871, K123501 – IM Total Femur – Biomet. Inc K912712, K090757 – Modular Hip – Biomet, Inc. (Taper Connection) K141331, K1405… | 2004 |
| * | K123501 | Oss Modular Stems, Oss Diaphyseal SegmentsSummary page 4…ned, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560) Legally marketed devices to which substantial equivalence is claimed: K033871, K123501 – IM Total Femur – Biomet. Inc K912712, K090757 – Modular Hip – Biomet, Inc. (Taper Connection) K141331, K140509 - Biom… | 2013 |
| * | K912712 | Biomet Modular Total Hip Femoral ComponentsSummary page 4…Polymer/Metal/Polymer (21 CFR 888.3560) Legally marketed devices to which substantial equivalence is claimed: K033871, K123501 – IM Total Femur – Biomet. Inc K912712, K090757 – Modular Hip – Biomet, Inc. (Taper Connection) K141331, K140509 - Biomet Orthopedic Salvage System – Biomet, Inc.… | 1991 |
| * | K090757 | Biomet Modular Femoral Revision SystemSummary page 4…Metal/Polymer (21 CFR 888.3560) Legally marketed devices to which substantial equivalence is claimed: K033871, K123501 – IM Total Femur – Biomet. Inc K912712, K090757 – Modular Hip – Biomet, Inc. (Taper Connection) K141331, K140509 - Biomet Orthopedic Salvage System – Biomet, Inc. (Indicati… | 2009 |
| * | K141331 | Biomet Orthopaedic Salvage System (Oss)Summary page 4…which substantial equivalence is claimed: K033871, K123501 – IM Total Femur – Biomet. Inc K912712, K090757 – Modular Hip – Biomet, Inc. (Taper Connection) K141331, K140509 - Biomet Orthopedic Salvage System – Biomet, Inc. (Indications) Device Description The OSS/Arcos IM Total Femur Rod is,… | 2014 |
| * | K140509 | Biomet Side Access Distal Femoral ExpandableSummary page 4…stantial equivalence is claimed: K033871, K123501 – IM Total Femur – Biomet. Inc K912712, K090757 – Modular Hip – Biomet, Inc. (Taper Connection) K141331, K140509 - Biomet Orthopedic Salvage System – Biomet, Inc. (Indications) Device Description The OSS/Arcos IM Total Femur Rod is, in simpl… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 20 of the 48 ancestors have a recall of any class.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
OSS INDICATIONS 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies. 5. Tumor resections. 6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head…
Read the full statement (340 words)
OSS INDICATIONS
1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.
These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA).
Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA).
*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
COMPRESS INDICATIONS
The Compress Segmental Femoral Replacement System is indicated for:
1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
The Compress Segmental Femoral Replacement System components are intended for uncemented use.
‘When components of the Orthopaedic Salvage System are used with Biomet’s Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.
EXPANDABLE INDICATIONS
The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
The devices are single use implants intended for implantation with bone cement or with Biomet Compress.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152621: OSS/Arcos IM Total Femur Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152621
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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